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Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players

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: NCT04159233
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Suzanne M. Bertisch, MD, MPH, Brigham and Women's Hospital

Brief Summary:

This pilot study is focused on estimating the impact of a tele-sleep intervention on patient-centered outcomes relevant to former football players, including a) sleep duration, quality, and daytime impairment; b) pain, pain catastrophizing, physical and emotional functioning; c) mood; d) quality of life, with the longer-term goal to evaluate the impact on cardiovascular health risk. The evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI) will be utilized and tailored it to meet the needs of former football players.

This pilot work will serve as the foundation for a larger, future clinical trial that utilizes a durable approach for improving sleep health with potential influence pain and quality of life as well as future studies to evaluate the implementation and scalability of BBTI in novel populations.


Condition or disease Intervention/treatment Phase
Sleep Insomnia Pain Quality of Life Behavioral: Brief Behavioral Therapy for Insomnia (BBTI) Not Applicable

Detailed Description:
The investigators will plan to enroll 40 participants. Players will be recruited from the Harvard Football Players Health Study cohort from across the US via email and telephone invitations. Following screening, if the participant is eligible and interested, they may consent to enroll in the study. Participants will receive evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI), tailored to meet the needs of former football players. BBTi is a brief, efficacious treatment that focuses on modifying behaviors, rather than cognitive domains. The treatment emphasizes education, motivational tools, and specific behavioral recommendations (e.g., restricting time in bed). BBTI has been previously delivered remotely and this intervention will be delivered by phone by sleep interventionists including trained social workers, psychologists, and nurse practitioners. Participants will complete an intake session with their interventionist followed by a 'treatment session' a week later wherein the interventionist will provide education about sleep regulation and create an individualized schedule of sleep/wake times for the participant. This will be followed by 3 brief weekly check-in calls to review progress, address questions and concerns, and adjust the behavioral treatment plan as the participant progresses. The participant will complete a daily sleep diary throughout the intervention to inform the treatment. Participants will also complete baseline, endpoint and follow-up questionnaires to assess outcomes and intervention acceptability and feasibility. Participants will receive compensation for their participation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Developing A Scalable Sleep Health Intervention to Improve Pain, Quality of Life, and Health in Former NFL Players
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI)
All participants will receive the same intervention in this pilot study.
Behavioral: Brief Behavioral Therapy for Insomnia (BBTI)
Participants will receive evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI), tailored to meet the needs of former football players. BBTi is a brief, efficacious treatment that focuses on modifying behaviors, rather than cognitive domains. The treatment emphasizes education, motivational tools, and specific behavioral recommendations (e.g., restricting time in bed) and will be administered through weekly phone calls with a trained sleep interventionist over 4-weeks.




Primary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint [ Time Frame: Week 4 ]
    PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.


Secondary Outcome Measures :
  1. PROMIS Sleep Disturbance, 8b Follow-up [ Time Frame: Week 12 ]
    PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

  2. PROMIS Sleep Impairment, 8a Endpoint [ Time Frame: Week 4 ]
    PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days. The measure includes 8-items with higher scores indicating greater sleep impairment. The minimum score is 8 and the maximum score 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

  3. PROMIS Sleep Impairment, 8a Follow-up [ Time Frame: Week 12 ]
    PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

  4. Response to treatment (baseline to endpoint) [ Time Frame: Week 0 vs. Week 4 ]
    Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined response to treatment as a change in the PSQI score of ≥3 points (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.

  5. Response to treatment (baseline to follow-up) [ Time Frame: Week 0 vs. Week 12 ]
    Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined response to treatment as a change in the PSQI score of ≥3 points (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.

  6. Remission of poor sleep symptoms (baseline to endpoint) [ Time Frame: Week 0 vs. Week 4 ]
    Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined remission as the response criterion (change in the PSQI score of ≥3 points) plus a final PSQI score <5 (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.

  7. Remission of poor sleep symptoms (baseline to follow-up) [ Time Frame: Week 0 vs. Week 12 ]
    Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined remission as the response criterion (change in the PSQI score of ≥3 points) plus a final PSQI score <5 (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.

  8. PROMIS Pain intensity, 3a (Endpoint) [ Time Frame: Week 4 ]
    PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Item responses are combined to yield a T-score with population mean of 50 and standard deviation of 10.

  9. PROMIS Pain intensity, 3a (Follow-up) [ Time Frame: Week 12 ]
    PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Item responses are combined to yield a T-score with population mean of 50 and standard deviation of 10.

  10. PROMIS Pain interference, 8a (Endpoint) [ Time Frame: Week 4 ]

    PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days.

    The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference. Item responses are combined to yield a standardized T-score with a mean of 50, and a standard deviation of 10.


  11. PROMIS Pain interference, 8a (Follow-up) [ Time Frame: Week 12 ]

    PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days.

    The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference. Item responses are combined to yield a standardized T-score with a mean of 50, and a standard deviation of 10.


  12. Insomnia Severity Index, ISI (Endpoint) [ Time Frame: Week 4 ]
    The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

  13. Insomnia Severity Index, ISI (Follow-up) [ Time Frame: Week 12 ]
    The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Able to communicate clearly in English
  • Have a digital device with reliable internet access
  • Sub-clinical insomnia (Insomnia Severity Index, score >7, sub-clinical threshold insomnia)
  • Able to give informed consent

Exclusion criteria

  • Prior participation in behavioral therapy for insomnia
  • Self-reported circadian phase irregularity/delay, including regular shift work
  • Previously diagnosed Narcolepsy, bipolar disorder or other major psychiatric disorders
  • Active alcohol abuse (Alcohol Use Disorders Identification Test, AUDIT-C ≥4) or drug abuse (Drug Abuse Screening Test, DAST-2 ≥1)
  • Current severe major depressive disorder (Patient Health Questionnaire-8, PHQ-8, score ≥20)
  • Use of seizure medication or seizure within the past 10 years
  • Untreated, previously diagnosed moderate to severe sleep apnea or excessive daytime sleepiness (defined by Epworth sleepiness scale score ≥16) with a self-reported sleep duration (>6 hours)

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): NCT04159233


Contacts
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Contact: Rebecca E Rottapel, MS, MPH 8573070343 rrottapel@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Rebecca Rottapel, MS, MPH    857-307-0343    rrottapel@bwh.harvard.edu   
Contact: Suzanne Bertisch, MD, MPH    (857) 307-0355    SBERTISCH@PARTNERS.ORG   
Principal Investigator: Suzanne M Bertisch, MD, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Investigators
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Principal Investigator: Suzanne Bertisch, MD, MPH Assistant Professor in Medicine, Physician/Clinical Investigator
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Responsible Party: Suzanne M. Bertisch, MD, MPH, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04159233    
Other Study ID Numbers: 2019P002027
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 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
Keywords provided by Suzanne M. Bertisch, MD, MPH, Brigham and Women's Hospital:
sleep
pain
professional athlete
National Football League
Behavioral intervention