Complementary Exercise-Based Therapy for Obstructive Sleep Apnea

Residual AHI, measured as described for Outcome Measure 1, is classified into four categories: normal (<5 events/hour), mild (5 to <15 events/hour), moderate (15 to <30 events/hour) and severe (≥30 events/hour). Improvement is defined as a shift to a lower category at Day 90 compared with baseline.

Percentage of participants whose residual AHI at Day 90 is reduced by at least 50% compared with baseline. Residual AHI is measured as described for Outcome Measure 1.

The oxygen desaturation index (ODI) is the number of oxygen desaturation episodes of at least [3% / 4%] from baseline saturation per hour of [recording time / estimated sleep time], measured by the pulse oximetry channel of the overnight cardiorespiratory polygraphy described for Outcome Measure 1. ODI is expressed in events per hour. Change is calculated as the Day 90 value minus the baseline value; a negative change indicates improvement.

Mean peripheral oxygen saturation (SpO2) over the recording period, measured by the pulse oximetry channel of the overnight cardiorespiratory polygraphy describedfor Outcome Measure 1, expressed as a percentage (%). Change is calculated as the Day 90value minus the baseline value; a positive change indicates improvement.

The lowest peripheral oxygen saturation (SpO2) recorded during the night bythe pulse oximetry channel of the overnight cardiorespiratory polygraphy described for Outcome Measure 1, expressed as a percentage (%). Change is calculated as the Day 90 value minus the baseline value; a positive change indicates improvement.

T90 is the percentage of total recording time spent with peripheral oxygensaturation (SpO2) below 90%, measured by the pulse oximetry channel of the overnight cardiorespiratory polygraphy described for Outcome Measure 1. Expressed as a percentage ofrecording time (%). Change is calculated as the Day 90 value minus the baseline value; anegative change indicates improvement.

The number of desaturation episodes during which peripheral oxygen saturation (SpO2) fell below 90%, counted over the entire overnight cardiorespiratory polygraphyrecording described for Outcome Measure 1. Expressed as the number of episodes per night. Change is calculated as the Day 90 value minus the baseline value; a negative changeindicates improvement.

The Epworth Sleepiness Scale (ESS) is an 8-item self-administered questionnaire assessing the likelihood of dozing off in 8 common daily situations. Each item is rated from 0 (would never doze) to 3 (high chance of dozing). The total score ranges from0 to 24. Higher scores indicate greater daytime sleepiness (worse outcome). A negative change from baseline indicates improvement.

Systolic blood pressure measured at rest at the study visit, expressed in millimeters of mercury (mmHg). Change is calculated as the Day 90 value minus the baseline value.

Diastolic blood pressure measured at rest at the study visit, expressed inmillimeters of mercury (mmHg). Change is calculated as the Day 90 value minus the baseline value.

Heart rate measured at rest at the study visit, expressed in beats per minute (bpm). Change is calculated as the Day 90 value minus the baseline value.

Body mass index calculated as body weight in kilograms divided by height inmeters squared (kg/m²), based on weight and height measured at the study visit. Change is calculated as the Day 90 value minus the baseline value.

FEV1 measured by spirometry performed according to ATS/ERS technical standards, expressed in liters (L). Change is calculated as the Day 90 value minus the baseline value.

FVC measured by spirometry performed according to ATS/ERS technical standards, expressed in liters (L). Change is calculated as the Day 90 value minus the baselinevalue.

Ratio of forced expiratory volume in 1 second to forced vital capacity, measured by spirometry and expressed as a percentage (%). Change is calculated as the Day 90 value minus the baseline value.

DLCO measured by the single-breath method according to ATS/ERS technical standards and corrected for hemoglobin concentration, expressed in mL/min/mmHg. Change iscalculated as the Day 90 value minus the baseline value.

The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-administered questionnaire assessing the frequency of depressive symptoms over the previous 2 weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. Higher scores indicate more severe depressive symptoms (worse outcome). A negative change from baseline indicates improvement.

The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-reportquestionnaire composed of three 7-item subscales (Depression, Anxiety, Stress) assessingsymptoms over the previous week. Each item is rated from 0 (did not apply to me at all)to 3 (applied to me very much or most of the time). The Depression subscale score is calculated by summing its 7 items and multiplying by 2, giving a range of 0 to 42. Higher scores indicate more severe depressive symptoms (worse outcome). A negative change from baseline indicates improvement.

The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-reportquestionnaire composed of three 7-item subscales (Depression, Anxiety, Stress) assessingsymptoms over the previous week. Each item is rated from 0 (did not apply to me at all)to 3 (applied to me very much or most of the time). The Anxiety subscale score is calculated by summing its 7 items and multiplying by 2, giving a range of 0 to 42. Higher scores indicate more severe anxiety symptoms (worse outcome). A negative change from baseline indicates improvement.

The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-reportquestionnaire composed of three 7-item subscales (Depression, Anxiety, Stress) assessingsymptoms over the previous week. Each item is rated from 0 (did not apply to me at all)to 3 (applied to me very much or most of the time). The Stress subscale score is calculated by summing its 7 items and multiplying by 2, giving a range of 0 to 42. Higher scores indicate more severe stress symptoms (worse outcome). A negative change from baselineindicates improvement.

The Calgary Sleep Apnea Quality of Life Index (SAQLI) is an obstructive sleep apnea-specific quality of life questionnaire. A 14-item version was used in this study. Each item is rated on a 7-point scale, and the total score is calculated as the meanof the 14 items, ranging from 1 to 7. Higher scores indicate better quality of life (better outcome). A positive change from baseline indicates improvement.

The EQ-5D-3L is a generic health-related quality of life instrument developed by the EuroQol Group, covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on 3 levels (no problems, some problems,extreme problems). Responses are converted into a single index value using the UK time trade-off (Dolan 1997) value set. Index values range from -0.594 to 1.000, where 1.000 represents full health and values below 0 represent health states valued as worse than death. Higher values indicate better health (better outcome).

The EQ VAS, part of the EQ-5D-3L, records the participant's self-rated overall health on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better self-rated health (better outcome).

The 36-Item Short Form Health Survey (SF-36) assesses 8 health domains. Item responses are linearly transformed to a 0 to 100 scale and averaged within each domain. The physical health composite score is the unweighted mean of the four physical domains (physical functioning, role limitations due to physical health, bodily pain, generalhealth) and ranges from 0 to 100. Higher scores indicate better physical health status(better outcome). A positive change from baseline indicates improvement.

The 36-Item Short Form Health Survey (SF-36) assesses 8 health domains. Item responses are linearly transformed to a 0 to 100 scale and averaged within each domain. The mental health composite score is the unweighted mean of the four mental domains(vitality, social functioning, role limitations due to emotional problems, mental health) and ranges from 0 to 100. Higher scores indicate better mental health status (betteroutcome). A positive change from baseline indicates improvement.

Cervical sagittal alignment measured by the Cobb method on a lateral cervical spine radiograph, expressed in degrees (°). An angle of 0° corresponds to a straightened cervical spine; higher values indicate greater cervical kyphosis (worse outcome). Change is calculated as the Day 90 value minus the baseline value.