Predictors of the Metabolic Effect of Sleep Loss

Obesity Clinical Trial

— SDBO  

Official title:

Predictors of the Metabolic Effect of Sleep Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965783
• Other study ID #: #15207A
• Secondary ID: 1 RO1 IIL075025
• Status: Completed
• Phase: N/A
• First received: August 25, 2009
• Last updated: September 4, 2013
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To test whether baseline levels of slow wave activity (SWA) during sleep are lower in obese adults, and even lower in persons with sleep disordered breathing (SDB) compared to lean adults.

To compare levels of SWA in individuals in relation to their sleep time, blood pressure, heart rate, and markers of glucose metabolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy,

• normal sleepers,

• lean, overweight,

• obese,

• pre menopausal

Exclusion Criteria:

• no shift workers or night-shift workers,

• no mental health disorders,

• no acute or chronic health conditions (stable, well controlled hypertension are accepted),

• no hormonal treatments,

• no substances that may interfere with sleep,

• problems with sleep

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea, Obstructive

Intervention

Other:
• Restriction
Time in bed for each subject is restricted by two hours per night for 4 nights
• Extension
Bedtime is extended by 2 hours per night for 4 nights

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between SWA, sleep duration,sleep architecture, and biomarkers of the metabolic syndrome in lean, obese with and without obstructive sleep apnea.		study completion	No