"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" | — |