NCT03733483: SIIB

Sleep Disruption Induced Impairments in Bone Formation

Completed NA Results posted Last updated 12 July 2021

What this trial tests

NA trial testing Sleep Deprivation in Healthy in 12 participants. Completed in 16 March 2020.

Timeline

17 January 2019

Primary endpoint
16 March 2020

16 March 2020

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	12
Start date	17 January 2019
Primary completion	16 March 2020
Estimated completion	16 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Sleep Deprivation

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University of Colorado, Denver

Who can join

Adults 20 to 65, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Serum Pro-collagen 1 Intact N-terminal Propeptide (P1NP) Primary · 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.

A marker of bone formation

Baseline

Group	Value	95% CI
Sleep Deprivation	72.1	± 4.4

Sleep Restricted

Group	Value	95% CI
Sleep Deprivation	67.4	± 4.4

Change in Serum C-telopeptide of Type 1 Collagen (CTX) Secondary · 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.

A marker of bone resorption

Baseline

Group	Value	95% CI
Sleep Deprivation	0.197	± 0.05

Sleep Restricted

Group	Value	95% CI
Sleep Deprivation	0.459	± 0.06

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sleep Deprivation

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (2 terms — click to expand)

Reaction	System	Sleep Deprivation
Dry eyes	Eye disorders	—
Irritation	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03733483 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bone Turnover Markers After Six Nights of Insufficient Sleep and Subsequent Recovery Sleep in Healthy Men.
   Swanson CM, Shanbhag P, Tussey EJ, Rynders CA, et al · · 2022 · cited 2× · PMID 35133471 · DOI 10.1007/s00223-022-00950-8