N/A
Completed N=27
Metabolic Study of Sleep Apnea in Men and Women
Obstructive Sleep Apnea (OSA)
Source: ClinicalTrials.gov NCT00706511 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Polysomnography - Apnea-hypopnea Index (AHI) — 11.4; 0.7; 6; 1.1 units on a scale
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.
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 | — |
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)
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. Informational only — not medical advice.