Trial results for a study investigating a lifestyle intervention for obesity and obstructive sleep apnea were posted on ClinicalTrials.gov on 2025-10-21, with 696 participants enrolled.
Background
Obesity is a significant health concern often linked with conditions like obstructive sleep apnea (OSA), which can reduce quality of life and increase cardiovascular disease risk. Although obesity is the primary reversible risk factor for OSA, patients frequently do not receive adequate weight loss care. Previous efficacy trials have shown that comprehensive lifestyle-based weight loss programs can improve weight and physiological measures of OSA severity, such as the apnea-hypopnea index (AHI).
Trial design
This completed study, designated as Phase NA, enrolled 696 participants to investigate conditions including Obesity and Obstructive Sleep Apnea. The trial compared a lifestyle intervention against usual care, aiming to assess its effectiveness and reach in improving health outcomes for patients with these prevalent obesity-related conditions.
Key results
The trial reported several key measurements and analyses comparing the lifestyle intervention group to the usual care control group.
- Change in Sleep-related Quality of Life (units on a scale):
- Lifestyle Intervention: Mean 1.43 (Standard Deviation 2.73)
- Usual Care Control: Mean 0.93 (Standard Deviation 2.89)
- Change in Weight (kg):
- Lifestyle Intervention: Mean -2.10 (Standard Deviation 6.75)
- Usual Care Control: Mean -0.88 (Standard Deviation 5.86)
- Cardiovascular Risk Scores (score on a scale):
- Lifestyle Intervention: Mean 0.22 (Standard Deviation 3.47)
- Usual Care Control: Mean -0.20 (Standard Deviation 3.65)
- PROMIS - Sleep Disturbance Survey Change (T-score):
- Lifestyle Intervention: Mean -3.34 (Standard Deviation 7.69)
- Usual Care Control: Mean -3.02 (Standard Deviation 6.76)
- PROMIS - Sleep Related Impairment Survey Change (T-score):
- Lifestyle Intervention: Mean -5.67 (Standard Deviation 8.84)
- Usual Care Control: Mean -3.13 (Standard Deviation 7.76)
- Systolic Blood Pressure From VA Medical Record (millimeters of mercury (mm Hg)):
- Lifestyle Intervention: Mean -0.22 (Standard Deviation 15.73)
- Usual Care Control: Mean -2.26 (Standard Deviation 15.06)
Mixed Models Analyses were conducted to compare changes between groups:
- A Mixed Models Analysis showed a mean difference (net) of 0.64 (95.0% CI: 0.25 to 1.04) with a p-value of 0.001.
- Another Mixed Models Analysis showed a mean difference (net) of -1.06 (95.0% CI: -2.05 to -0.06) with a p-value of 0.037.
- A third Mixed Models Analysis showed a mean difference (net) of 0.37 (95.0% CI: -0.12 to 0.86) with a p-value of 0.135.
- A fourth Mixed Models Analysis showed a mean difference (net) of -0.97 (95.0% CI: -2.01 to 0.07) with a p-value of 0.068.
- A fifth Mixed Models Analysis showed a mean difference (net) of -2.71 (95.0% CI: -3.83 to -1.6) with a p-value of 0.001.
- A sixth Mixed Models Analysis showed a mean difference (net) of 0.87 (95.0% CI: -1.16 to 2.89) with a p-value of 0.401.
What this means
The results indicate that the lifestyle intervention led to statistically significant differences in several measured outcomes compared to usual care. Specifically, three mixed models analyses reported p-values of 0.001, 0.037, and 0.001, with corresponding mean differences (net) of 0.64, -1.06, and -2.71 respectively. These findings suggest that the lifestyle intervention had a measurable impact on certain health parameters in participants with obesity and obstructive sleep apnea, although the specific outcomes for each analysis are not detailed in the provided data.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05104450, titled "Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach", were posted on 2025-10-21 on clinicaltrials.gov.