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Parent-Adolescent Interpersonal Processes in the Science of Behavior Change

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926221
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, Berkeley

Brief Summary:
This study seeks to examine a novel interpersonal target; namely, parent-teen conversations about youth health behavior change. The rationale is that parents have profound impacts on teen risk and vulnerability. Yet parents receive minimal training in the elements of conversations that optimally inspire their children toward engaging in healthy behaviors. A theoretically grounded and reliable taxonomy of behavior change techniques (BCTs) will be used as a basis for scientifically deriving the conversational elements, or micro-mechanisms, that reduce parent-teen conflict and facilitate upward spirals of healthful behavior change. This proposal builds on pilot data from a recently completed NICHD-funded R01 in which a sleep treatment improved sleep and reduced risk on selected outcomes in youth. While sleep-related health behaviors will be the focus of this R21, the research is designed to be relevant to a broad range of health behavior change. As part of an Administrative Supplement to the R21 awarded in Fall, 2019, two changes are made. First, measures of psychophysiology have been added to the Hot Topics Task. Second, an independent sample of teens who are healthy sleepers (n = 20), and their parents, will be tested on the protocol twice, 9 weeks apart. This comparison group is included to control for the passage of time and for completing the protocol twice. They do not receive an intervention.

Condition or disease Intervention/treatment Phase
Sleep Deprivation Adolescent Behavior Behavioral: Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: PBC_I plus TranS-C
The Parent Behavior Change Intervention (PBC-I) is a behavioral intervention intended to teach parent behavior change techniques to better support their adolescents to improve sleep health behavior. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Behavioral: Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
PBC-I will be administered to the parent and TranS-C will be administered to the teenager. Both interventions are cognitive-behavioral and comprised of six weekly sessions. Parent and teenager sessions will be held in parallel.




Primary Outcome Measures :
  1. Number of BCTs used by parent coded from the Hot Topics Task [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure.

  2. Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure. 20 items each on a true/false scale. Total score ranges from 0 to 20 and is computed by adding up total score points. Higher scores indicate more general conflict.

  3. Decisional balance proportion [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Measured by Decision Balance Worksheet. Youth measure.

  4. Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. 19 items each on a 4-point scale. Global score ranges from 0 to 21 and is computed by totaling seven component scores. Lower scores indicate healthier sleep quality.


Secondary Outcome Measures :
  1. Type of BCTs used by parent coded from the Hot Topics Task [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure.

  2. Number of negative and positive communication behaviors coded from the Hot Topics Task [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure.

  3. Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire. [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. 20 items each on a true/false scale. Total score ranges from 0 to 20 and is computed by adding up total score points. Higher scores indicate more general conflict.

  4. Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. 18 items on a 7-point Likert scale, with three subscales being used: Interest/Enjoyment, Perceived Competence, and Effort/Importance. Total score ranges from 3 to 21 (1-7 for each subscale score) and is computed by averaging items within each subscale and adding the 3 subscale scores.

  5. Regularity in sleep midpoint across the week measured via daily sleep diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure.

  6. Regularity in sleep midpoint across the week measured via actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure.

  7. Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. 10 items are weighed on either 4- or 5-point scales. Total score ranges from 10 to 43 and is computed by adding up total points. Scores between 10 and 20 indicate eveningness, scores between 28 and 42 indicate morningness, scores between 21 and 27 are categorized as neither.


Other Outcome Measures:
  1. Number of BCTs used by parent coded from the End of Treatment Conversation [ Time Frame: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure.

  2. Type of BCTs used by parent coded from the End of Treatment Conversation [ Time Frame: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure.

  3. Number of negative and positive communication behaviors coded from the End of Treatment Conversation [ Time Frame: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure.

  4. Number of conflicts and the mean anger intensity for parent [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Measured via Issues Checklist. Parent measure.

  5. Number of conflicts and the mean anger intensity for youth [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Measured via Issues Checklist. Youth measure.

  6. Youth's subjective Bedtime measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Self-report of Bedtime in hour : minutes. Bedtime discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  7. Youth's subjective Wakeup Time measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Self-report of Wakeup Time in hour : minutes. Wakeup Time discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  8. Youth's subjective Sleep Onset Latency (SOL) measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Self-report of SOL in hour : minutes. SOL discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  9. Youth's subjective Wake After Sleep Onset (WASO) measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Self-report of WASO in hour : minutes. WASO discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  10. Youth's subjective Number of Awakenings measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Self-report of Number of Awakenings. Number of Awakenings discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  11. Youth's subjective Time in Bed (TIB) measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Self-report of TIB in hour : minutes. TIB discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  12. Youth's subjective Naps measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Self-report of Naps in hour : minutes. Naps discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  13. Youth's subjective Total Sleep Time (TST) deviation score from developmental norms measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. TST in minutes is computed for weeknights and weekend nights by using self-report of daily Bedtime, Wakeup Time, Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Naps. TST discrepancy between weeknights and weekend nights is calculated. TST deviation score from developmental norms is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post-assessment.

  14. Youth's subjective Sleep Midpoint measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Sleep Midpoint in hour : minutes is computed for weeknights and weekend nights by subtracting Waketime from Bedtime and dividing the difference by TST [(bedtime-waketime)/TST]. Sleep Midpoint discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  15. Youth's subjective Total Wake Time measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youths measure. Total Wake Time in minutes is computed for weeknights and weekend nights by adding up Sleep Onset Latency and Wake After Sleep Onset (WASO). Total Wake Time discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  16. Youth's subjective Sleep Efficacy measured via Daily Sleep Diary [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Sleep Efficacy in minutes is computed for weeknights and weekend nights by dividing Total Sleep Time (TST) by Time in Bed (TIB) times 100 (TST/TIB x 100). Sleep Efficacy discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.

  17. Youth's objective Bedtime measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Objective method of monitoring Bedtime in hour : minutes. Bedtime discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  18. Youth's objective Wakeup Time measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Objective method of monitoring Wakeup Time in hour : minutes. Wakeup Time discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  19. Youth's objective Sleep Onset Latency (SOL) measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Objective method of monitoring SOL in hour : minutes. SOL discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  20. Youth's objective Wake After Sleep Onset (WASO) measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Objective method of monitoring WASO in hour : minutes. WASO discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  21. Youth's objective Number of Awakenings measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Objective method of monitoring Number of Awakenings in hour : minutes. Number of Awakenings discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  22. Youth's objective Time in Bed (TIB) measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Objective method of monitoring TIB in hour : minutes. TIB discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  23. Youth's objective Naps measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Objective method of monitoring Naps in hour : minutes. Naps discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  24. Youth's objective Total Sleep Time (TST) deviation score from developmental norms measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. TST in minutes is computed for weeknights and weekend nights by using Bedtime, Wakeup Time, Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Naps. TST discrepancy between weeknights and weekend nights is calculated. TST deviation score from developmental norms is calculated. Actigraphy is obtained over a period of 7 days at pre and post-assessment.

  25. Youth's objective Sleep Midpoint measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Sleep Midpoint in hour : minutes is computed for weeknights and weekend nights by subtracting Waketime from Bedtime and dividing the difference by TST [(bedtime-waketime)/TST]. Sleep Midpoint discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  26. Youth's objective Total Wake Time measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Total Wake Time in minutes is computed for weeknights and weekend nights by adding up Sleep Onset Latency and Wake After Sleep Onset (WASO). Total Wake Time discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  27. Youth's objective Sleep Efficacy measured via Actigraphy [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Youth measure. Sleep Efficacy in minutes is computed for weeknights and weekend nights by dividing Total Sleep Time (TST) by Time in Bed (TIB) times 100 (TST/TIB x 100). Sleep Efficacy discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.

  28. Parent's perception of coercion in parent-child relationship measured via Parent-Child Coercion Scale [ Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure. 9 items each on a 5-point scale. Total score is computed by adding up total points and dividing them by the number of items completed. Total score ranges from 1 to 5. Higher scores indicate more coercion.

  29. Youth's systolic blood pressure reactivity [ Time Frame: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart. ]
    Youth measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.

  30. Youth's diastolic blood pressure reactivity [ Time Frame: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart. ]
    Youth measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.

  31. Youth's heart rate variability [ Time Frame: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart. ]
    Youth measure. Heart rate variability is measured using an ambulatory electrocardiogram during the Hot Topic Task. HRV will be calculated as the root mean square of successive differences (RMSSD), which is the square root of the mean squared differences between successive beat-to-beat RR intervals.

  32. Parent's systolic blood pressure reactivity [ Time Frame: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart. ]
    Parent measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.

  33. Parent's diastolic blood pressure reactivity [ Time Frame: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart. ]
    Parent measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.

  34. Parent's heart rate variability [ Time Frame: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart. ]
    Parent measure. Heart rate variability is measured using an ambulatory electrocardiogram during the Hot Topic Task. HRV will be calculated as the root mean square of successive differences (RMSSD), which is the square root of the mean squared differences between successive beat-to-beat RR intervals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 10 and 18 and living with a parent or guardian
  2. Lowest quartile of the widely used and well-validated Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and
  3. Youth self-reported weekday sleep onset time for the past month later than 10:40 pm for 10- to 13-year- olds; 11:00pm for 14-16 year olds, and later than 11:20 for 17-18 year olds at least 3 nights per week;
  4. English language fluency;
  5. able and willing to give informed assent;
  6. at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.

Exclusion Criteria:

  1. An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
  2. evidence of sleep apnea, restless legs or periodic limb movements;
  3. significantly impairing pervasive developmental disorder;
  4. history of substance dependence in the past six months;
  5. suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;
  6. Participants will not be excluded if medications are stable (> 4 weeks).

Inclusion criteria (control group):

  1. Age between 10 and 18 and living with a parent or guardian
  2. (CMEP; 28 or higher) on Children's Morningness-Eveningness Preferences Scale
  3. Item #6 on the Pittsburgh Sleep Quality Index (PSQI) rated 'fairly' or 'very good'
  4. English language fluency;
  5. able and willing to give informed assent;
  6. at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.

Exclusion Criteria (control group)

  1. An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
  2. evidence of sleep apnea, restless legs or periodic limb movements;
  3. significantly impairing pervasive developmental disorder;
  4. history of substance dependence in the past six months;
  5. suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;
  6. Participants will not be excluded if medications are stable (> 4 weeks).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926221


Contacts
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Contact: Allison Harvey, PhD + 1-510-642-7138 aharvey@berkeley.edu
Contact: Lu Dong, PhD +1-510-643-3797 lu.dong@berkeley.edu

Locations
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United States, California
University of California, Berkeley Recruiting
Berkeley, California, United States, 94720-1650
Contact: Allison G. Harvery, Ph.D.    510-642-7138    aharvey@berkeley.edu   
Contact: Alice Mullin    (510) 643-3797    alicemullin@berkeley.edu   
Sponsors and Collaborators
University of California, Berkeley
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Allison Harvey, PhD University of California, Berkeley
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Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT03926221    
Other Study ID Numbers: R21_parent_teen_study
R21HD097819 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders