N/A
Completed N=47
Estimating Apnea Phenotypes From Polysomnography: Oxygen
Source: ClinicalTrials.gov NCT01751971 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Apnea-hypopnea Index — 40.5; 57.9; 48.5; 74.3 events/hour — p=0.4
Summary
This study seeks to employ advanced methods to estimate the individual factors contributing to sleep apnea from standard recordings made during routine clinical sleep studies. This study focuses on breathing control or "loop gain" as one of the factors contributing to sleep apnea. Increased levels of oxygen in the air is known to make breathing more stable by lowering "loop gain". Here, our goal is to use a new method capable of detecting a reduction in loop gain with oxygen. The investigators also aim to test whether a high loop gain measured at baseline/placebo predicts a greater improvement in sleep apnea with oxygen therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Index |
40.5; 57.9; 48.5; 74.3; 35.9; 48.5 | 0.4 |
| SECONDARY Frequency of EEG Arousals (Events Per Hour) |
35.9; 50.3; 20.8; 39.7; 45.4; 57.0 | — |
| SECONDARY Overnight Change in Systolic Blood Pressure |
-0.8; 3.0; -2.8; 3.4; 0.5; 2.8 | — |
| SECONDARY Overnight Change in Diastolic Blood Pressure |
0.9; 4.1; -0.7; 6.4; 2.0; 2.5 | — |
| SECONDARY Subjective Sleep Quality (Oxygen vs Sham) |
0.34; 0.69; 0.14 | — |
| SECONDARY Subjective Sleepiness/Alertness (Stanford Sleepiness Scale) |
2.13; 2.03; 2.14; 2.11; 2.13; 1.99 | — |
Eligibility Criteria
Inclusion Criteria
- Apnea/hypopnea index >20 events per hour
- Age 20-79 years
Exclusion Criteria
- COPD with desaturation (resting SpO2<96%)
- Use of respiratory stimulants or depressants
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01751971). 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.