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Trial record 1 of 1 for:    NCT03733483
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Sleep Disruption Induced Impairments in Bone Formation (SIIB)

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ClinicalTrials.gov Identifier: NCT03733483
Recruitment Status : Completed
First Posted : November 7, 2018
Results First Posted : July 12, 2021
Last Update Posted : July 12, 2021
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Behavioral: Sleep Deprivation
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sleep Deprivation
Hide Arm/Group Description Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Sleep Deprivation
Hide Arm/Group Description Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
28.3  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
0
   0.0%
Male
12
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
12
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  16.7%
White
6
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Change in Serum Pro-collagen 1 Intact N-terminal Propeptide (P1NP)
Hide Description A marker of bone formation
Time Frame 24 hour serum draw before and after 6 night sleep restriction. Pre measures taken on night 1 through day 2. Post measures taken on night 7 through day 8. A fasting blood sample will be taken each morning of the inpatient stay.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Deprivation
Hide Arm/Group Description:
Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
Overall Number of Participants Analyzed 12
Mean (Standard Error)
Unit of Measure: ng/mL
Baseline 72.1  (4.4)
Sleep Restricted 67.4  (4.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sleep Deprivation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on P1NP levels. Change in P1NP in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change in Serum C-telopeptide of Type 1 Collagen (CTX)
Hide Description A marker of bone resorption
Time Frame 24 hour serum draw before and after 6 night sleep restriction. Pre measures taken on night 1 through day 2. Post measures taken on night 7 through day 8. A fasting blood sample will be taken each morning of the inpatient stay.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Deprivation
Hide Arm/Group Description:
Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
Overall Number of Participants Analyzed 12
Mean (Standard Error)
Unit of Measure: ng/mL
Baseline 0.197  (0.05)
Sleep Restricted 0.459  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sleep Deprivation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on CTX levels. Change in CTX in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Adverse events data were collected while subjects were enrolled in the study. This included during their screening visit and during the 16 -37 days they were enrolled in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sleep Deprivation
Hide Arm/Group Description Sleep Deprivation: Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
All-Cause Mortality
Sleep Deprivation
Affected / at Risk (%)
Total   0/12 (0.00%)    
Hide Serious Adverse Events
Sleep Deprivation
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sleep Deprivation
Affected / at Risk (%) # Events
Total   2/12 (16.67%)    
Eye disorders   
Dry eyes * [1]  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Irritation * [2]  1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One participant experienced eye discomfort during the inpatient sleep restriction portion of the study. This was resolved with saline eye drops
[2]
One participant experienced skin irritation due to the tape used with our IV catheter. Skin irritation resolved within 7 days.
1) A protocol deviation resulted in slightly longer sleep duration on one night in one participant. Results were unchanged when data were re-analyzed without data from that participant. 2) This data was from a small cohort of young, healthy, physically active men. 3) Activity restrictions imposed during sleep restriction may not accurately reflect activity during real-life sleep restriction. 4) Study diets provided may not accurately replicate real-life changes in diet due to sleep restriction.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine Swanson, MD, MCR, Assistant Professor
Organization: University of Colorado, Anschutz Medical Campus
Phone: (303)724-0073
EMail: christine.swanson@cuanschutz.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03733483    
Other Study ID Numbers: 18-0015
K23AR070275 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2018
First Posted: November 7, 2018
Results First Submitted: June 18, 2021
Results First Posted: July 12, 2021
Last Update Posted: July 12, 2021