An interventional study of Multimodal Exercise, Respiratory and Cervical-Postural Rehabilitation Program and Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea, sponsored by bioROne. Completed at 1 site in Romania. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by bioROne · Not applicable, Interventional, and Treatment
This randomized interventional study evaluates a complementary exercise-based therapy in adults with moderate-to-severe obstructive sleep apnea who are receiving continuous positive airway pressure (CPAP) therapy. A total of 24 participants are assigned to either a complementary rehabilitation program in addition to usual care or to usual care alone. The rehabilitation program is performed for 90 days and includes two approximately 45-minute sessions per day, combining physical exercise, breathing exercises, and cervical-postural rehabilitation. The study evaluates changes in the apnea-hypopnea index, nocturnal oxygen saturation, sleep fragmentation, daytime sleepiness, quality of life, psychological symptoms, cardiovascular and respiratory parameters, body mass index, and cervical spine alignment.
The study investigates whether a complementary multimodal rehabilitation program can improve clinical and functional parameters in patients with moderate-to-severe obstructive sleep apnea. Participants continue their conventional CPAP therapy throughout the study. Those allocated to the intervention group additionally perform a structured 90-day rehabilitation program under medical and physiotherapy guidance, while participants in the control group continue usual treatment and habitual daily activities.
The intervention includes physical conditioning, respiratory exercises, and cervical-postural exercises. Outcomes are assessed before and after the intervention period and include sleep-related respiratory indices, nocturnal oxygenation, sleep fragmentation, daytime sleepiness, cardiovascular and anthropometric parameters, respiratory function, psychological status, health-related quality of life, and radiographic cervical alignment.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 24 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →This is the only study on the registry with bioROne as lead sponsor.
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Exclusion Criteria:
Participants continue prescribed CPAP and usual clinical care and additionally receive a 90-day multimodal rehabilitation program. The program includes two approximately 45-minute sessions per day and combines physical conditioning, neuromotor and postural exercises, cervical mobility and relaxation exercises, controlled breathing and respiratory-awareness techniques, and relaxation/body-awareness strategies.
Behavioral: Multimodal Exercise, Respiratory and Cervical-Postural Rehabilitation Program · Device: Continuous Positive Airway Pressure (CPAP)
Participants continue prescribed CPAP and usual clinical care without receiving the study-delivered multimodal rehabilitation program. Participants are asked to maintain their habitual daily activities during the study period.
Device: Continuous Positive Airway Pressure (CPAP)
A 90-day structured rehabilitation program including physical conditioning, neuromotor and postural exercises, cervical mobility and relaxation exercises, controlled breathing and respiratory-awareness techniques, and relaxation/body-awareness strategies. Participants continue prescribed CPAP and usual clinical care throughout the intervention.
Participants continue their prescribed home CPAP therapy and other clinically indicated usual care throughout the study period.
Change in Residual Apnea-Hypopnea Index (AHI) During CPAP Therapy
The residual apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of \[recording time / estimated sleep time\], measured by overnight cardiorespiratory polygraphy without electroencephalography, performed while the participant was using their home CPAP device. Events are scored according to American Academy of Sleep Medicine (AASM) criteria: apnea is defined as a reduction in airflow of at least 90% lasting at least 10 seconds, and hypopnea as a reduction in airflow of at least 30% lasting at least 10 seconds, associated with an oxygen desaturation of at least \[3% / 4%\]. AHI isexpressed in events per hour. Change is calculated as the Day 90 value minus the baseline value; a negative change indicates improvement.
Time frame: Baseline and Day 90
Percentage of Participants With Improvement in Residual Apnea-Hypopnea Index (AHI) Severity Category
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.
Time frame: Baseline and Day 90
Percentage of Participants With at Least 50% Reduction in Residual Apnea-HypopneaIndex (AHI)
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.
Time frame: Baseline and Day 90
Change in Oxygen Desaturation Index (ODI)
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.
Time frame: Baseline and Day 90
Change in Mean Nocturnal Oxygen Saturation (SpO2)
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.
Time frame: Baseline and Day 90
Change in Minimum Nocturnal Oxygen Saturation (SpO2)
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.
Time frame: Baseline and Day 90
Change in Percentage of Recording Time With Oxygen Saturation Below 90% (T90)
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.
Time frame: Baseline and Day 90
Change in Number of Oxygen Desaturations Below 90%
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.
Time frame: Baseline and Day 90
Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale (ESS)
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.
Time frame: Baseline and Day 90
Change in Resting Systolic Blood Pressure
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.
Time frame: Baseline and Day 90
Change in Resting Diastolic Blood Pressure
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.
Time frame: Baseline and Day 90
Change in Resting Heart Rate
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.
Time frame: Baseline and Day 90
Change in Body Mass Index (BMI)
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.
Time frame: Baseline and Day 90
Change in Forced Expiratory Volume in 1 Second (FEV1)
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.
Time frame: Baseline and Day 90
Change in Forced Vital Capacity (FVC)
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.
Time frame: Baseline and Day 90
Change in FEV1/FVC Ratio
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.
Time frame: Baseline and Day 90
Change in Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide(DLCO)
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.
Time frame: Baseline and Day 90
Change in Depressive Symptom Severity Assessed by the Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: Baseline and Day 90
Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21)
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.
Time frame: Baseline and Day 90
Change in Anxiety Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21)
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.
Time frame: Baseline and Day 90
Change in Stress Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21)
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.
Time frame: Baseline and Day 90
Change in Sleep Apnea-Specific Quality of Life Assessed by the Calgary Sleep Apnea Quality of Life Index (SAQLI)
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.
Time frame: Baseline and Day 90
Change in EQ-5D-3L Index Value
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).
Time frame: Baseline and Day 90
Change in EQ Visual Analogue Scale (EQ VAS) Score
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).
Time frame: Baseline and Day 90
Change in 36-Item Short Form Health Survey (SF-36) Physical Health Composite Score
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.
Time frame: Baseline and Day 90
Change in 36-Item Short Form Health Survey (SF-36) Mental Health Composite Score
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.
Time frame: Baseline and Day 90
Change in Cervical Sagittal Alignment Assessed by the Cobb Angle
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.
Time frame: Baseline and Day 90
Plan to share: No
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Ran from May 2025 to primary completion in May 2026, 12 months.
Of 511 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's 12 months is below that.
Counting every sponsor, half of 621 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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