Weight loss and lifestyle intervention for cardiorespiratory fitness in obstructive sleep apnea: The INTERAPNEA trial.

INTRODUCTION: Although recent trials have shown benefits of weight loss and lifestyle interventions on obstructive sleep apnea (OSA) severity and comorbidities, the effect of these interventions on cardiorespiratory fitness (CRF) remains unknown. This study aimed to investigate the effects of an interdisciplinary weight loss and lifestyle intervention on CRF and self-reported physical fitness in adults with OSA. METHODS: Eighty-nine men aged 18-65 years with moderate-to-severe OSA and a body mass index ≥25 kg/m2 were randomly assigned to a usual-care group or an 8-week interdisciplinary weight loss and lifestyle intervention. CRF was assessed through the 2-km walking test, and the International Fitness Scale (IFIS) was used to assess self-reported physical fitness. RESULTS: As compared with usual-care, the intervention group had greater improvements at intervention endpoint in objective CRF (6% reduction in 2-km walking test total time, mean between-group difference, -1.7 min; 95% confidence interval, -2.3 to -1.1), and self-reported overall physical fitness (18% increase in IFIS total score, mean between-group difference, 2.3; 95% CI 1.2 to 3.3). At 6 months after intervention, the intervention group also had greater improvements in both 2-km walking test total time (10% reduction) and IFIS total score (22% increase), with mean between-group differences of -2.5 (CI 95%, -3.1 to -1.8) and 3.0 (CI 95%, 1.8 to 4.1), respectively. CONCLUSIONS: An 8-week interdisciplinary weight loss and lifestyle intervention resulted in significant and sustainable improvements in CRF and self-reported physical fitness in men with overweight/obesity and moderate-to-severe OSA. STUDY REGISTRATION: ClinicalTrials.gov registration (NCT03851653).

Interdisciplinary Weight Loss and Lifestyle Intervention for Daily Functioning and Psychiatric Symptoms in Obstructive Sleep Apnea: The INTERAPNEA Randomized Clinical Trial.

Objective: Impaired daily functioning and psychiatric symptoms are highly prevalent in obstructive sleep apnea (OSA); however, the effects of weight loss and lifestyle interventions on these symptoms remain uncertain. This study aimed to evaluate the efficacy of an interdisciplinary weight loss and lifestyle intervention on impaired functioning, psychological distress, anxiety, and depression among men with moderate-to-severe OSA and obesity.Methods: This study was a randomized clinical trial conducted from April 2019 to October 2020. Men aged 18-65 years with moderate-to-severe OSA and obesity were randomly assigned to usual care (continuous positive airway pressure) or an 8-week weight loss and lifestyle intervention. Primary outcomes were changes from baseline to intervention endpoint and 6 months after intervention in daily functioning (measured by the Functional Outcomes of Sleep Questionnaire [FOSQ]); psychological distress (evaluated through the General Health Questionnaire [GHQ]); and anxiety and depression symptoms (measured by the State-Trait Anxiety Inventory [STAI], State-Trait Depression Inventory [STDI], and Beck Depression Inventory [BDI]).Results: Eighty-nine participants underwent randomization (mean [± SD] age, 54 ± 8 years; mean apnea-hypopnea index, 41 ± 22 events/h); 49 were assigned to usual care and 40 to the intervention. As compared with usual care, the intervention group had greater improvements in daily functioning (mean between-group difference in FOSQ score, 2.3; 95% confidence interval, 1.5 to 3.2), psychological distress (GHQ score, -10.3; -15.3 to -5.1), state anxiety (STAI-State score, -7.0; -11.0 to -3.0), trait anxiety (STAI-Trait score, -6.1; -9.5 to -2.8), state depression (STDI-State score, -2.4; -4.3 to -0.4), trait depression (STDI-Trait score, -3.8; -5.6 to -2.1), and general depression (BDI score, -2.0; -3.2 to -0.8) at intervention endpoint. Similar changes were observed at 6 months after intervention.Conclusions: This study provides the first evidence suggesting that an interdisciplinary weight loss and lifestyle intervention improves OSA-related impaired daily functioning and psychiatric symptoms. These findings should be considered when evaluating the potential benefits of this behavioral approach for OSA.Trial Registration: ClinicalTrials.gov Identifier: NCT03851653.

Effect of a Weight Loss and Lifestyle Intervention on Dietary Behavior in Men with Obstructive Sleep Apnea: The INTERAPNEA Trial.

This study investigated the effects of an eight-week interdisciplinary weight loss and lifestyle intervention on dietary behavior in men who were overweight/had obesity and moderate-to-severe obstructive sleep apnea (OSA). It was based on data from INTERAPNEA (ClinicalTrials.gov ID: NCT03851653); a randomized clinical trial conducted from April 2019 to April 2020. Men aged 18-65 years with moderate-to-severe OSA and a body mass index ≥25 kg/m2 were randomly assigned to a usual-care group or an eight-week interdisciplinary weight loss and lifestyle intervention combined with usual-care. Dietary behavior was assessed through the Food Behavior Checklist (FBC) and the Mediterranean Diet Adherence Screener (MEDAS). Of the 89 participants who underwent randomization, 75 completed the intervention endpoint assessment, 89 participants being therefore included in the intention-to-treat analyses, and 75 in the per-protocol approach. As compared with usual-care, the intervention group had greater improvements at intervention endpoint in dietary behavior, as measured by the FBC total score (20% increase in FBC total score, mean between-group difference, 8.7; 95% confidence interval, 5.7 to 11.7), and MEDAS total score (33% increase in MEDAS total score, mean between-group difference, 2.1; 95% CI 1.3 to 2.9). At 6 months after intervention, the intervention group also had greater improvements in both the FBC total score (15% increase) and MEDAS total score (25% increase), with mean between-group differences of 7.7 (CI 95%, 4.4 to 10.9) and 1.7 (CI 95%, 0.9 to 2.6), respectively. An eight-week interdisciplinary weight loss and lifestyle intervention resulted in meaningful and sustainable improvements in dietary behavior, including adherence to the Mediterranean diet in men who were overweight/ had obesity and CPAP-treated moderate-to-severe OSA.

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

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.

Anxiety and Depression in Patients with Obstructive Sleep Apnoea before and after Continuous Positive Airway Pressure: The ADIPOSA Study.

The prevalence and treatment response of depression and anxiety symptoms in obstructive sleep apnoea (OSA), although widely addressed in research and clinical settings, still remain unclear due to overlapping symptoms. The ADIPOSA study sought to elucidate the presence of non-overlapping symptoms of depression and anxiety in patients with moderate to severe OSA before and after continuous positive airway pressure (CPAP) treatment. Forty-eight adults aged 18-80 (68.75% men) with moderate to severe OSA were enrolled in this twelve-week longitudinal single-arm trial and completed a full-night ambulatory sleep diagnostic test and an assessment of cognitive-affective depression and anxiety symptoms using the Beck-Depression Inventory-Fast Screen (BDI-FS), the State-Trait Depression Inventory (IDER) and the State-Trait Anxiety Inventory (STAI). We found no cognitive-affective depression or anxiety symptoms of clinical relevance at baseline. The amelioration of depression and anxiety symptoms after CPAP use was only statistically significant when considering anxiety-trait (p < 0.01; d = 0.296) and euthymia (p < 0.05; d = 0.402), the distinctive component of depression. Although dysthymia or high negative affect remained unchanged, CPAP may be effective at reducing the lack of positive affect, a well-established health-protective factor. However, not until depression and anxiety disorders related to OSA are accurately measured in clinical and research settings will it be possible to obtain robust conclusions on the occurrence and amelioration of these symptoms after treatment.

Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: Rationale, Design and Methodology of the INTERAPNEA Study.

Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation. INTERAPNEA is a randomised controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 84 males aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, health-related quality of life, and cost-effectiveness. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition.