NCT00965783

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

2.5 years

First QC Date

August 25, 2009

Last Update Submit

September 4, 2013

Conditions

ApneaObstructive Sleep Apnea (OSA)Obesity

Keywords

Sleep, Apnea, OSA, obese, middle-aged

Outcome Measures

Primary Outcomes (1)

  • Correlation between SWA, sleep duration,sleep architecture, and biomarkers of the metabolic syndrome in lean, obese with and without obstructive sleep apnea.

    study completion

Study Arms (2)

1

EXPERIMENTAL

Sleep time restriction

Other: Restriction

2

EXPERIMENTAL

Sleep time extension

Other: Extension

Interventions

RestrictionOTHER

Time in bed for each subject is restricted by two hours per night for 4 nights

1
ExtensionOTHER

Bedtime is extended by 2 hours per night for 4 nights

2

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy,
  • normal sleepers,
  • lean, overweight,
  • obese,
  • pre menopausal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

ApneaSleep Apnea, ObstructiveObesity

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSleep Apnea SyndromesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)