NCT00706511

Brief Summary

The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in men and women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2012

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2012

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

March 24, 2020

Completed
Last Updated

March 24, 2020

Status Verified

September 1, 2016

Enrollment Period

4.7 years

First QC Date

June 25, 2008

Results QC Date

June 28, 2019

Last Update Submit

March 23, 2020

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

OSADiabetesMetabolismGender

Outcome Measures

Primary Outcomes (4)

  • Polysomnography - Apnea-hypopnea Index (AHI)

    apnea-hypopnea index: number of apneas and hypopneas per hour of recording; a measure of the severity of obstructive sleep apnea; varies from min=0 to max=120; AHI between 0 and \<5: no significant sleep apnea; AHI between 5 and \<15: mild sleep apnea; AHI between 15 and \<30: moderate sleep apnea; AHI of 30 and above: severe sleep apnea.

    After 6 weeks of CPAP (Treatment)

  • Polysomnography - Minutes of N3 Stage

    Stage N3, sometimes referred to as "delta sleep" or "slow wave sleep", is characterized by slow waves in the electro-encephalogram (EEG) that reflect synchronization of firing of cortical neurons. N3 sleep is considered the most restorative stage of sleep for both the brain and the rest of the body.

    After 6 weeks of CPAP (Treatment)

  • Polysomnography - Minutes of REM Stage

    After 6 weeks of CPAP (Treatment)

  • Polysomnography - Sleep Efficiency

    Sleep efficiency: a measure of objective sleep quality; calculated from the polygraphic sleep recording as the ratio of time spent asleep during the scheduled sleep period to total scheduled sleep period. Expressed in %. Varies from 0% (the subject did not sleep at all) to 100% (the subject spent the entire scheduled sleep period asleep).

    After 6 weeks of CPAP (Treatment)

Secondary Outcomes (3)

  • IVGTT (Intravenous Tolerance Test) - Sensitivity Index (SI)

    After treatment (6 weeks)

  • IVGTT (Intravenous Tolerance Test) - Acute Insulin Response

    After treatment (6 weeks)

  • IVGTT (Intravenous Tolerance Test) - Disposition Index (DI)

    After treatment (6 weeks)

Study Arms (2)

Group with OSA

EXPERIMENTAL

Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.

Device: CPAP

Group without OSA

NO INTERVENTION

Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol

Interventions

CPAPDEVICE

CPAP (continuous positive airway pressure) treatment at home for 6 weeks

Group with OSA

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese (BMI of at least 30 kg/m2)

You may not qualify if:

  • Clinically significant depression
  • Positive pregnancy test
  • Diagnosis of diabetes mellitus
  • Hypertension (systolic \> 140 mmHg and/or diastolic \> 90 mmHg) not well-controlled on stable medication with either ACE inhibitors or diuretics
  • Habitual alcohol use
  • Excessive caffeine intake of more than 300 mg/day
  • Hemoglobin \< 11g/dL and/or hematocrit \< 33%
  • Systemic illnesses, including heart, renal, liver, or malignant disease
  • Taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study
  • Travel across time zones during the 4 weeks prior to starting the study
  • Irregular sleeping habits (including shift work)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism

Chicago, Illinois, 60637, United States

Location

Related Publications (7)

  • Tasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proc Natl Acad Sci U S A. 2008 Jan 22;105(3):1044-9. doi: 10.1073/pnas.0706446105. Epub 2008 Jan 2.

    PMID: 18172212BACKGROUND

  • Tasali E, Van Cauter E, Ehrmann DA. Relationships between sleep disordered breathing and glucose metabolism in polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):36-42. doi: 10.1210/jc.2005-1084. Epub 2005 Oct 11.

    PMID: 16219719BACKGROUND

  • Tasali E, Mokhlesi B, Van Cauter E. Obstructive sleep apnea and type 2 diabetes: interacting epidemics. Chest. 2008 Feb;133(2):496-506. doi: 10.1378/chest.07-0828.

    PMID: 18252916BACKGROUND

  • Knutson KL, Spiegel K, Penev P, Van Cauter E. The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007 Jun;11(3):163-78. doi: 10.1016/j.smrv.2007.01.002. Epub 2007 Apr 17.

    PMID: 17442599BACKGROUND

  • Van Cauter E, Holmback U, Knutson K, Leproult R, Miller A, Nedeltcheva A, Pannain S, Penev P, Tasali E, Spiegel K. Impact of sleep and sleep loss on neuroendocrine and metabolic function. Horm Res. 2007;67 Suppl 1:2-9. doi: 10.1159/000097543. Epub 2007 Feb 15.

    PMID: 17308390BACKGROUND

  • Knutson KL, Ryden AM, Mander BA, Van Cauter E. Role of sleep duration and quality in the risk and severity of type 2 diabetes mellitus. Arch Intern Med. 2006 Sep 18;166(16):1768-74. doi: 10.1001/archinte.166.16.1768.

    PMID: 16983057BACKGROUND

  • Latta F, Leproult R, Tasali E, Hofmann E, L'Hermite-Baleriaux M, Copinschi G, Van Cauter E. Sex differences in nocturnal growth hormone and prolactin secretion in healthy older adults: relationships with sleep EEG variables. Sleep. 2005 Dec;28(12):1519-24. doi: 10.1093/sleep/28.12.1519.

    PMID: 16408410BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDiabetes MellitusCoitus

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSexual BehaviorBehavior

Results Point of Contact

Title
Eve Van Cauter, PhD
Organization
University of Chicago
evcauter@bsd.uchicago.edu
773-702-0169

Study Officials

  • Eve Van Cauter, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 27, 2008

Study Start

December 1, 2007

Primary Completion

August 16, 2012

Study Completion

August 22, 2012

Last Updated

March 24, 2020

Results First Posted

March 24, 2020

Record last verified: 2016-09

Locations

US(1)