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HealthySIIBNCT03733483

Sleep Disruption Induced Impairments in Bone Formation

A study testing Sleep Deprivation in people with Healthy, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Sleep Deprivation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
17 Jan 2019to 16 Mar 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical & Translational Research Centers (CTRC) UCHealth

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone Formation

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
Being tested
Sleep Deprivation
Keywords
Bone, Sleep Restriction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep DeprivationBehavioural

    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 groups in NCT03733483
Study groupRoleWhat they receive
Sleep DeprivationExperimentalNot described
Receives: Behavioral: Sleep Deprivation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    A marker of bone formation

    Measured: 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)

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

    A marker of bone resorption

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start17 Jan 2019
  3. Primary completion16 Mar 2020
  4. Study completion16 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Subjects are their own controls, with baseline measurements serving as the control values prior to intervention.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733483
Sponsor's protocol ID
18-0015
Other IDs
K23AR070275
Acronym
SIIB
Status last verified
Jun 2021
First submitted
5 Nov 2018
Last updated
12 Jul 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 28973223

  • 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.

    PubMed 35133471

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Deprivation in people with Healthy, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03733483, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

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Sleep Disruption Induced Impairments in Bone Formation | AzTrials