Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial

Abstract

Importance: Obesity is the leading cause of obstructive sleep apnea (OSA); however, the effects of weight loss and lifestyle interventions on OSA and comorbidities remain uncertain.

Objective: To evaluate the effect of an interdisciplinary weight loss and lifestyle intervention on OSA and comorbidities among adults with moderate to severe OSA and overweight or obesity.

Design, setting, and participants: The Interdisciplinary Weight Loss and Lifestyle Intervention for OSA (INTERAPNEA) study was a parallel-group open-label randomized clinical trial conducted at a hospital-based referral center in Granada, Spain, from April 1, 2019, to October 23, 2020. The study enrolled 89 Spanish men aged 18 to 65 years with moderate to severe OSA and a body mass index (calculated as weight in kilograms divided by height in meters squared) of 25 or greater who were receiving continuous positive airway pressure (CPAP) therapy. The sole inclusion of men was based on the higher incidence and prevalence of OSA in this population, the differences in OSA phenotypes between men and women, and the known effectiveness of weight loss interventions among men vs women.

Interventions: Participants were randomized to receive usual care (CPAP therapy) or an 8-week weight loss and lifestyle intervention involving nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care.

Main outcomes and measures: The primary end point was the change in the apnea-hypopnea index (AHI) from baseline to the intervention end point (8 weeks) and 6 months after intervention. Secondary end points comprised changes in other OSA sleep-related outcomes, body weight and composition, cardiometabolic risk, and health-related quality of life.

Results: Among 89 men (mean [SD] age, 54.1 [8.0] years; all of Spanish ethnicity; mean [SD] AHI, 41.3 [22.2] events/h), 49 were randomized to the control group and 40 were randomized to the intervention group. The intervention group had a greater decrease in AHI (51% reduction; change, -21.2 events/h; 95% CI, -25.4 to -16.9 events/h) than the control group (change, 2.5 events/h; 95% CI, -2.0 to 6.9 events/h) at the intervention end point, with a mean between-group difference of -23.6 events/h (95% CI, -28.7 to -18.5 events/h). At 6 months after intervention, the reduction in AHI was 57% in the intervention group, with a mean between-group difference of -23.8 events/h (95% CI, -28.3 to -19.3 events/h). In the intervention group, 18 of 40 participants (45.0%) no longer required CPAP therapy at the intervention end point, and 6 of 40 participants (15.0%) attained complete OSA remission. At 6 months after intervention, 21 of 34 participants (61.8%) no longer required CPAP therapy, and complete remission of OSA was attained by 10 of 34 participants (29.4%). In the intervention vs control group, greater improvements in body weight (change, -7.1 kg [95% CI, -8.6 to -5.5 kg] vs -0.3 kg [95% CI, -1.9 to 1.4 kg]) and composition (eg, change in fat mass, -2.9 kg [95% CI, -4.5 to -1.3 kg] vs 1.4 kg [95% CI, -0.3 to 3.1 kg]), cardiometabolic risk (eg, change in blood pressure, -6.5 mm Hg [95% CI, -10.3 to -2.6 mm Hg] vs 2.2 mm Hg [95% CI, -2.1 to 6.6 mm Hg]), and health-related quality of life (eg, change in Sleep Apnea Quality of Life Index, 0.8 points [95% CI, 0.5-1.1 points] vs 0.1 points [95% CI, -0.3 to 0.4 points]) were also found at the intervention end point.

Conclusions and relevance: In this study, an interdisciplinary weight loss and lifestyle intervention involving Spanish men with moderate to severe OSA and had overweight or obesity and were receiving CPAP therapy resulted in clinically meaningful and sustainable improvements in OSA severity and comorbidities as well as health-related quality of life. This approach may therefore be considered as a central strategy to address the substantial impact of this increasingly common sleep-disordered breathing condition.

Trial registration: ClinicalTrials.gov Identifier: NCT03851653.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.. Study Flow Diagram

Figure 2.. Apnea-Hypopnea Index End Point

The ends of the boxes in the box plots are located at the first and third quartiles, with the black line in the middle illustrating the median. Whiskers extend to the upper and lower adjacent values, the location of the furthest point within a distance of 1.5 IQRs from the first and third quartiles. The parallel line plot contains 1 vertical line for each participant, which extends from their baseline value to their 8-week or 6-month value. Descending lines indicate an improvement in the outcome. Baseline values are placed in ascending order for the control group and descending order for the intervention group. The apnea-hypopnea index measures the number of apnea and hypopnea events per hour of sleep, with 0-4 events indicating normal (no obstructive sleep apnea [OSA]), 5-14 events indicating mild OSA, 15-30 events indicating moderate OSA, and >30 events indicating severe OSA; a change of at least 15 events is considered clinically meaningful and would move a participant 2 levels in severity status (eg, from severe to mild OSA, indicating a benefit for health).