CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Sleep Deprivationbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03733483
NCT03733483N/ACompleted
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Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone Formation

University of Colorado, Denver·interventional·Posted Nov 7, 2018·Updated Jul 12, 2021

In Brief

A clinical study evaluating Sleep Deprivation for Healthy. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This is a small intervention study with healthy males aged 20-65 years old who habitually sleep 7-9 hours/night.This study investigates if and how sleep restriction, independent of circadian misalignment (e.g. shift work, jet lag), induces a decrease in the bone formation marker Procollagen I Intact N-Terminal Propeptide (PINP). The specific aim is to evaluate the mechanistic underpinnings for the relationship between sleep restriction and suppression of bone formation. The study will enroll 12 healthy male participants and have a two-week intervention after enrollment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 7, 2018
Enrollment StartJan 17, 2019
Primary CompletionMar 16, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.7 years ago

Interventions

Sleep Deprivationbehavioral

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.