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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
Last Update Posted : March 19, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE November 5, 2018
First Posted Date  ICMJE November 7, 2018
Last Update Posted Date March 19, 2020
Actual Study Start Date  ICMJE January 17, 2019
Actual Primary Completion Date March 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
Change in serum pro-collagen 1 intact N-terminal propeptide (P1NP) [ 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. ]
A marker of bone formation
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
Change in serum pro-collagen 1 intact N-terminal propeptide (P1NP) [ Time Frame: 24 hour serum draw before and after 6 day 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • Change in serum C-telopeptide of type 1 collagen (CTX) [ 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. ]
    A marker of bone resorption
  • Change in sclerostin [ 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. ]
    A marker of osteocyte function and activity
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Change in serum C-telopeptide of type 1 collagen (CTX) [ Time Frame: 24 hour serum draw before and after 6 day 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
  • Change in sclerostin [ Time Frame: 24 hour serum draw before and after 6 day 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 osteocyte function and activity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Disruption Induced Impairments in Bone Formation
Official Title  ICMJE Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone Formation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Subjects are their own controls, with baseline measurements serving as the control values prior to intervention.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE Experimental: Sleep Deprivation
Intervention: Behavioral: Sleep Deprivation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 16, 2020
Actual Primary Completion Date March 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • Any clinically significant unstable medical or surgical condition within the last year (treated or untreated), including history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure-sleep loss has been used clinically to induce seizures in patients with epilepsy). Given the wide range of illnesses that are encountered in medical practice, it would not be possible to provide a comprehensive list of each and every disease that could serve as grounds for exclusion for the subject. However, the following is a list of illness categories that would certainly be grounds for exclusion: Connective Tissue and Joint Disorders; Neurologic/cognitive Disorders; Musculoskeletal Disorders; Immune Disorders; Chronobiologic Disorders; Cardiovascular Disorders; Respiratory Disorders; Kidney Disorders; Infectious Diseases; Hematopoietic Disorders; Neoplastic Diseases; and Endocrine and Metabolic Diseases.
  • 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
  • Any clinically significant psychiatric condition, as defined by DSM-V. Individuals with a history of most psychiatric illnesses or psychiatric disorders will be excluded, such as but not limited to depression, anxiety, alcoholism, drug dependency, schizophrenic disorders, and personality disorders (performed by medical history and physician interview). However, a personal history of limited prior counseling, psychotherapy (e.g., for adjustment reactions) will NOT be exclusionary. Evaluation of Psychiatric/Psychological Suitability:

    • Subjects must demonstrate a full understanding of the requirements and demands of the study.
    • Each subject will complete psychological screening questionnaires. Exclusionary: Center for Epidemiological Studies Depression (CES-D) ≥ 16;. Subject responses to the CES-D are reviewed immediately and appropriate referrals are made if necessary.
    • 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.
    • Use of anti-depressants or any like therapeutics prescribed by a physician is exclusionary
  • 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).
  • Dwelling below Denver altitude (1,600 m) 6 months prior to testing;
  • Greater than moderate caffeine (>500 mg/day) or alcohol use (>14 standard drinks/week or >5 drinks in one sitting);
  • Subjects with a history of heparin-induced thrombocytopenia (HIT) or an allergy to heparin;
  • Inability to travel to the CU-AMC campus for study visits.
  • Individuals with restrictive diets (e.g., vegan)
  • Individuals with 25OHD < 20 ng/mL;
  • Individuals with eGFR < 60 mL/min/1.73m2 as this is known to affect CTX measurements;
  • T-score ≤ -2.5 (men ≥50 years old) or Z-score < -2.0 (men <50 years old) for bone mineral density (BMD) at the L-spine, femoral neck, or total hip on baseline DXA as compared to the DXA machine's normative database;
  • Symptoms of active illness (e.g., fever); note that subject can be studied at a later date.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03733483
Other Study ID Numbers  ICMJE 18-0015
K23AR070275 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Christine Swanson, MD, MCR University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP