Sleep Disruption Induced Impairments in Bone Formation

NCT03733483 | Completed Results

• 2 other identifiers: 18-0015K23AR070275
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bone; Sleep Restriction

Outcome Measures

Primary Outcomes (1)

• Change in Serum Pro-collagen 1 Intact N-terminal Propeptide (P1NP)

  A marker of bone formation

  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.

Secondary Outcomes (1)

• Change in Serum C-telopeptide of Type 1 Collagen (CTX)

  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.

Study Arms (1)

Sleep Deprivation

EXPERIMENTAL

Behavioral: Sleep Deprivation

Interventions

Sleep Deprivation BEHAVIORAL

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.

Sleep Deprivation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• o Adult men aged 20-65 years old who habitually sleep 7-9 hours/night.

You may not qualify if:

• Regularly go to sleep after midnight;
• Shift work 1 year prior to study;
• Travel \>1 time zone 4 weeks prior to study or need to travel during study;
• More than moderate activity level (\>3 days of exercise per week \>30 min of exercise per session);
• Current smokers (or within the previous year of study);
• Positive drug test at screening or laboratory admission;
• BMI \> 30 kg/m2;
• Individuals who are concurrently participating in another research protocol that would influence their safe participation in this study. For example, participants involved in a study that requires blood draws or ingestion of experimental medication as this would increase the risk of participation in our study and/or compromise study results.
• Self-reported or newly diagnosed medical condition that is still being investigated or is not under good control, including those identified on screening labs such as:
• Out-of-range values measured on a fasting blood sample: glucose \> 100 mg/dl, thyroid stimulating hormone \<0.5 or \>5.0 uU/ml, abnormal alkaline phosphatase \<39 or \>117 U/l, creatinine, or hemoglobin \<14.5 g/dl men
• Subjects must demonstrate a full understanding of the requirements and demands of the study.
• Individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressants, neuroleptic medications or major tranquilizers will be excluded from study.
• Individuals with any clinically significant sleep disorder; Diagnosis or symptoms of sleep disorders (history of significant parasomnia as an adult \[night terrors, frequent sleep walking\], insomnia, including but not limited to hypersomnias such as apnea, periodic limb movements, narcolepsy). Sleep disorders will be screened by self-report and physician interview including use of validated sleep questionnaires (PSQI, Epworth sleepiness scale, and Berlin sleep questionnaire for sleep apnea).
• Individuals on medications known to affect bone turnover (e.g. glucocorticoids, osteoporosis medications);
• Use of medications/supplements/drugs that impact sleep or bone metabolism (such as but not limited to sleep medications, marijuana etc.) within one month (participants can be studied at a later date).

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Clinical & Translational Research Centers (CTRC) UCHealth

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Swanson CM, Shea SA, Wolfe P, Cain SW, Munch M, Vujovic N, Czeisler CA, Buxton OM, Orwoll ES. Bone Turnover Markers After Sleep Restriction and Circadian Disruption: A Mechanism for Sleep-Related Bone Loss in Humans. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3722-3730. doi: 10.1210/jc.2017-01147.

  PMID: 28973223 BACKGROUND

• Swanson CM, Shanbhag P, Tussey EJ, Rynders CA, Wright KP Jr, Kohrt WM. Bone Turnover Markers After Six Nights of Insufficient Sleep and Subsequent Recovery Sleep in Healthy Men. Calcif Tissue Int. 2022 Jun;110(6):712-722. doi: 10.1007/s00223-022-00950-8. Epub 2022 Feb 8.

  PMID: 35133471 DERIVED

Limitations and Caveats

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.

Results Point of Contact

• Title: Christine Swanson, MD, MCR, Assistant Professor
• Organization: University of Colorado, Anschutz Medical Campus

christine.swanson@cuanschutz.edu

(303)724-0073

Study Officials

• Christine Swanson, MD, MCR

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects are their own controls, with baseline measurements serving as the control values prior to intervention.

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: January 17, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: July 12, 2021
• Results First Posted: July 12, 2021

Record last verified: 2021-06

Locations

US (1)