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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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Sleep Deprivation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Official Title: Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone Formation
Actual Study Start Date : January 17, 2019
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020

Arm Intervention/treatment
Experimental: Sleep Deprivation 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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733483

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United States, Colorado
Clinical & Translational Research Centers (CTRC) UCHealth
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Christine Swanson, MD, MCR University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03733483    
Other Study ID Numbers: 18-0015
K23AR070275 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2018    Key Record Dates
Results First Posted: July 12, 2021
Last Update Posted: July 12, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Sleep Restriction