N/A N=27 Treatment

Metabolic Study of Sleep Apnea in Men and Women

Obstructive Sleep Apnea (OSA)

Bottom Line

View on ClinicalTrials.gov: NCT00706511 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Polysomnography - Apnea-hypopnea Index (AHI) — 11.4; 0.7; 6; 1.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CPAP (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Polysomnography - Apnea-hypopnea Index (AHI)	11.4; 0.7; 6; 1.1	—
PRIMARY Polysomnography - Minutes of N3 Stage	58.1; 53.7; 75.7; 66.6	—
PRIMARY Polysomnography - Minutes of REM Stage	98.2; 101.5; 107.8; 111.1	—
PRIMARY Polysomnography - Sleep Efficiency	88.9; 89.9; 86.5; 89.7	—
SECONDARY IVGTT (Intravenous Tolerance Test) - Sensitivity Index (SI)	1.226; 1.106; 2.32; 4.195	—
SECONDARY IVGTT (Intravenous Tolerance Test) - Acute Insulin Response	1061; 623; 734; 1020	—
SECONDARY IVGTT (Intravenous Tolerance Test) - Disposition Index (DI)	1159; 683; 1257; 3718	—

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.

Eligibility Criteria

Inclusion Criteria

Obese (BMI of at least 30 kg/m2)

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00706511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.