Original ArticleEffects of an individualized exercise training program on severity markers of obstructive sleep apnea syndrome: a randomised controlled trial
Introduction
Obstructive sleep apnea (OSA) is a common sleep breathing disorder characterized by recurrent episodes of upper airway obstruction leading to intermittent hypoxia, arousals, increasing of sympathetic activity, oxidative stress, systemic inflammation and changes in intrathoracic pressure [1]. Excessive daytime sleepiness (EDS) is a cardinal symptom of OSA and is also associated with impaired quality of life, increased risk for accidents and metabolic and cardiovascular diseases [[2], [3], [4], [5]].
Continuous positive airway pressure (CPAP) is the first-line treatment of OSA resulting in decrease of apnea-hypopnea index (AHI), EDS, and improvement of sleep quality. However, long-term CPAP effectiveness remains limited by low adherence [6] and no randomized controlled trial has demonstrated a key protective effect in prevention of cardiovascular diseases [7]. CPAP therapy showed no effect on weight loss, energy expenditure, and no clinical significant impact on metabolic disorders or biomarkers associated with OSA [8]. Other treatments such as oral appliances or upper airway surgery only partially correct OSA, may have side effects, and their efficacy on the metabolic and cardiovascular consequences of OSA are poorly studied [9].
OSA is closely related to being overweight/obese, with a bidirectional link. Obesity is the most important risk factor for OSA [10] and OSA by itself can contribute to weight gain [11]. Moreover, patients with OSA present a decreased level of physical activity [12]. Lifestyle modification including diet and exercise training may be effective in reducing weight and severity of OSA, and are therefore recommended for the management of OSA [13,14].
Currently, few studies addressed the impact of non-pharmacological strategies such as hypocaloric diets and exercise training on severity of OSA. Recent meta-analysis showed a significant decrease in AHI and subjective sleepiness after exercise training regardless of weight loss [15,16]. The mechanisms underlying such improvement remain unclear; however a reduction of adipose tissue and in fluid shift in the upper airway area, an increase in oropharyngeal muscle strength, a change in humoral mediators of inflammation and metabolism, and a modification of sleep architecture with increased slow wave sleep associated with an increased respiratory stability may attenuate the propensity towards airway collapse during sleep [15,16]. The benefits of exercise training may also reduce severity of comorbidities associated with OSA (eg, diabetes, hypertension or cardiovascular diseases) and increasing physical activity is recommended to prevent cardiovascular diseases [15]. We previously showed positive effects of exercise training on cardiometabolic parameters and subjective EDS assessed by the Epworth Sleepiness Scale (ESS) in OSA patients [17], but its impact on objective sleepiness had not been evaluated.
The aim of this randomized, parallel-design study was to evaluate the efficacy of an individualized exercise training (IET) program with educational sessions compared to educational sessions only in patients with low physical activity level and moderate-to-severe OSA over an eight-week duration on severity markers of OSA: (1) change in AHI at endpoint vs baseline, (2) changes in EDS assessed by questionnaire and objective tests, and (3) subgroups analyses of patients according to their age, gender, BMI, ESS and AHI levels.
Section snippets
Study design
The REEVASAS trial was a randomized, controlled, parallel-design study of the efficacy of an IET program with educational sessions vs educational sessions only over an eight-week duration in patients with moderate-to-severe OSA.
All participants were admitted to the Sleep Unit, Department of Neurology, University Hospital Center of Montpellier and gave their written informed consent. The study was conducted in accordance with the CONSORT ethical guidelines and was approved by the local ethics
Patients
Of the 68 patients who were randomized, 34 were in the IG and 34 in the CG (Fig. 1). Two patients randomized to IG and two patients randomized to CG were not eligible to continue the trial due to non-respect of selection criteria (due to a posteriori double blind rescoring of PSG to validate thresholds of baseline AHI). One death occurred in IG (unrelated to study). Of the 63 remaining patients, nine (four in IG and five in CG) discontinued the trial prior to endpoint without a post baseline
Discussion
In adult patients with moderate-to-severe OSA, IET did not decrease AHI compared to the control group, but a significant reduction in AHI was found from baseline to end of the study in the group with IET. Compared to CG, IET resulted in greater decrease in AHI during REM sleep and a significant increase in mean sleep latency on the MSLT. Besides, IET improve severity of fatigue, insomnia and depressive symptoms.
While the primary outcome was not reached, we found a reduction of 21.5% in AHI in
Study funding
This was not an industry-supported study. This work was supported by a national grant (PHRC interregional).
Y Dauvilliers received funds for seminars, board engagements and travel to conferences by UCB Pharma, Jazz, Theranexus, Idorsia, Flamel and Bioprojet.
F Bughin, M Desplan, C Mestejanot, MC Picot, F Roubille, D Jaffuel, J Mercier, I Jaussent report no disclosures.
CRediT authorship contribution statement
F. Bughin: Investigation, Data curation, Writing - original draft. M. Desplan: Investigation, Data curation, Funding acquisition, Writing - review & editing. C. Mestejanot: Investigation, Data curation, Writing - review & editing. M.C. Picot: Methodology, Validation, Resources, Writing - review & editing. F. Roubille: Investigation, Data curation, Writing - review & editing. D. Jaffuel: Investigation, Data curation, Writing - review & editing. J. Mercier: Methodology, Validation, Writing -
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