Complementary Exercise-Based Therapy for Obstructive Sleep Apnea

NCT07891247 | Completed

• 1 other identifier: OSA-REHAB-PILOT-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Moderate-to-severe obstructive sleep apnea; CPAP; Exercise therapy; Respiratory rehabilitation; Cervical posture; Physical rehabilitation; Sleep-disordered breathing; Cervical alignment

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 90

Secondary Outcomes (26)

• Percentage of Participants With Improvement in Residual Apnea-Hypopnea Index (AHI) Severity Category

  Baseline and Day 90

• Percentage of Participants With at Least 50% Reduction in Residual Apnea-HypopneaIndex (AHI)

  Baseline and Day 90

• Change in Oxygen Desaturation Index (ODI)

  Baseline and Day 90

• Change in Mean Nocturnal Oxygen Saturation (SpO2)

  Baseline and Day 90

• Change in Minimum Nocturnal Oxygen Saturation (SpO2)

  Baseline and Day 90

Study Arms (2)

Multimodal Rehabilitation Plus Usual Care

EXPERIMENTAL

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)

Usual Care

ACTIVE COMPARATOR

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)

Interventions

Multimodal Exercise, Respiratory and Cervical-Postural Rehabilitation Program BEHAVIORAL

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.

Multimodal Rehabilitation Plus Usual Care

Continuous Positive Airway Pressure (CPAP) DEVICE

Participants continue their prescribed home CPAP therapy and other clinically indicated usual care throughout the study period.

Multimodal Rehabilitation Plus Usual Care; Usual Care

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 75 years
• Diagnosis of moderate obstructive sleep apnea (apnea-hypopnea index \[AHI\] 15-30 events/hour) or severe obstructive sleep apnea (AHI \>30 events/hour), established at least 3months before enrollment
• Use of home continuous positive airway pressure (CPAP) therapy for at least 3 months
• Loss of cervical lordosis (straightening or kyphosis of the cervical spine) on lateralcervical spine radiograph
• Signed informed consent for study participation
• Signed agreement regarding the confidentiality and processing of personal data

You may not qualify if:

• Anemia (hemoglobin ≤10 g/dL in women or ≤12 g/dL in men)
• Stroke within the previous 3 months
• Acute coronary syndrome within the previous 3 months
• Persistent hemodynamic instability
• Scheduled coronary artery bypass graft surgery
• Severe chronic kidney disease
• New York Heart Association (NYHA) class IV heart failure
• Decompensated heart failure
• Unstable exertional angina
• Dementia
• Acute painful exacerbation of osteoarticular disease
• Systolic blood pressure \>170 mmHg at screening

Sponsors & Collaborators

• bioROne: lead

Study Sites (1)

Clinical Rehabilitation Hospital Iași

Iași, Iaşi, 700661, Romania

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Respiratory Rate; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment and statistical analysis were performed using coded group identifiers. Personnel delivering the rehabilitation intervention were aware of treatment allocation because of the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, two-arm, parallel-group interventional study comparing a 90-day complementary multimodal rehabilitation program plus usual care with usual care alone in adults with moderate-to-severe obstructive sleep apnea.

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 23, 2026
• Study Start: May 6, 2025
• Primary Completion: May 7, 2026
• Study Completion: May 8, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)