Moderate to severe obstructive sleep apnea (OSA) in adults living with overweight or obesity
Conditions
Brief summary
Change in AHI from baseline at week 52
Detailed description
Percent change in AHI from baseline at week 52 Achieving ≥ 50% AHI reduction from baseline at week 52 Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤10 at week 52 Change in Sleep Apnea-specific Hypoxic burden (%/min/hour) from baseline at week 52, Percent change in body weight from baseline at week 52 Change in high sensitivity C-reactive protein (hs-CRP) from baseline at week 52 Change in SBP (mmHg) from baseline at Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score from baseline at week 52"
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in AHI from baseline at week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in AHI from baseline at week 52 Achieving ≥ 50% AHI reduction from baseline at week 52 Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤10 at week 52 Change in Sleep Apnea-specific Hypoxic burden (%/min/hour) from baseline at week 52, Percent change in body weight from baseline at week 52 Change in high sensitivity C-reactive protein (hs-CRP) from baseline at week 52 Change in SBP (mmHg) from baseline at Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score from baseline at week 52" | — |