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Obstructive Sleep ApneaNCT07889154

Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea

A study testing Physical Activity Education in people with Obstructive Sleep Apnea and Sleep Quality, run by Medipol University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Although exercise and physical activity have shown beneficial effects in individuals with obstructive sleep apnea (OSA), evidence regarding the effects of daily physical activity habits on sleep quality and respiratory parameters remains limited. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Physical Activity Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Oct 2026to 1 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individuals diagnosed with mild to severe obstructive sleep apnea (OSA) based on laboratory polysomnography (AHI: 5-30 events/hour).
  • Individuals diagnosed by a pulmonologist within the past year who initiated CPAP therapy no more than 12 months ago and demonstrate regular use.
  • Individuals with habitual snoring.
  • Individuals who have not participated in OSA-focused physiotherapy interventions within the past 3 months.

Who cannot join

  • Body mass index (BMI) >40 kg/m².
  • Severe substance or alcohol dependence.
  • Regular use of sedatives, muscle relaxants, or opioids that may affect sleep patterns.
  • Pregnancy or postpartum period (<6 months).
  • Medical contraindications to physical activity according to American College of Sports Medicine (ACSM) guidelines, such as unstable coronary artery disease or decompensated heart failure.
  • History of stroke or significant respiratory, neuromuscular, inflammatory, or other disorders causing hypercapnia.
  • Craniofacial abnormalities, severe upper airway obstruction, or secondary respiratory diseases such as chronic obstructive pulmonary disease (COPD).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gülay Aras Bayram, PhD contact

+905054966284

garas@medipol.edu.tr

Devrim Tarakci, PhD contact

+905322052282

dtarakci@medipol.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Medipol Universty

    Istanbul, Göztepe

    Gülay Aras Bayram, +905054966284, garas@medipol.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Physical Activity Habits on Sleep Quality and Respiratory Parameters in Individuals With Obstructive Sleep Apnea

Although exercise and physical activity have shown beneficial effects in individuals with obstructive sleep apnea (OSA), evidence regarding the effects of daily physical activity habits on sleep quality and respiratory parameters remains limited. This study aims to investigate these associations in individuals with OSA.

Read the detailed description

Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent upper airway collapse during sleep, leading to apneas and hypopneas. OSA negatively affects sleep quality, daytime functioning, and overall health and is associated with cardiovascular and metabolic disorders. Although continuous positive airway pressure (CPAP) is the primary treatment, adherence may be challenging. Physical activity and exercise have shown beneficial effects on OSA symptoms, sleep quality, and respiratory function. However, evidence regarding the relationship between habitual daily physical activity and these outcomes remains limited. Therefore, this study aims to investigate the effects of physical activity habits on sleep quality and respiratory parameters in individuals with OSA.

Being tested
Physical Activity Education
Keywords
Obstructive Sleep Apnea, Physical Activity Habits, Sleep Health
Medical subject headings
Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity EducationBehavioural

    Participants will receive physical activity education supported by illustrated materials and brochures. Recommendations will include: (1) aerobic exercise, with at least 150 minutes of moderate-intensity activity weekly (e.g., walking or cycling) over at least 3 days; (2) muscle-strengthening exercises targeting major muscle groups 2-3 days per week, with 3 sets of 8-15 repetitions; (3) balance and flexibility exercises 3 days per week; and (4) diaphragmatic breathing exercises for 15-30 minutes per session, 3 days per week. Exercise sessions will include 5-10 minutes of warm-up and cool-down. Periodic follow-up contacts will encourage adherence throughout the 24-week intervention. All participants will continue prescribed CPAP therapy.

Study groups in NCT07889154
Study groupRoleWhat they receive
Control Group (CG)No interventionParticipants will continue using physician-prescribed continuous positive airway pressure (CPAP) therapy and will be instructed to use CPAP every night for 24 weeks. No additional physical activity education will be provided as part of the study intervention.
Physical Activity Education Group (PAEG)ExperimentalParticipants will receive physical activity education at baseline, supported by visual materials and brochures. The education will include moderate-intensity aerobic and muscle-strengthening activities in accordance with established physical activity guidelines. Participants will be contacted periodically to assess adherence to physical activity recommendations. Participants will continue their prescribed CPAP therapy throughout the 24-week study period.
Receives: Behavioral: Physical Activity Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index (PSQI)

    A 19-item self-report questionnaire assessing sleep quality and disturbances over the previous month, including sleep duration, latency, efficiency, and daytime dysfunction. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. Scores above 5 indicate poor sleep quality.

    Measured: 0.,12., and 24. weeks

  2. Average Nightly CPAP Usage

    Average duration of continuous positive airway pressure (CPAP) use per night, measured in hours per night using data downloaded from the CPAP device. The average nightly usage will be calculated over the device-data assessment period. Good adherence will be defined as CPAP use for at least 4 hours per night on at least 5 nights per week.

    Measured: 0., and 24. weeks

  3. Average CPAP Mask Leak

    Average mask leak during CPAP use, assessed using data downloaded from the CPAP device over the device-data assessment period. Mask leak will be reported using the unit provided by the device (L/min). Good adherence will be defined as CPAP use for at least 4 hours per night on at least 5 nights per week.

    Measured: 0., and 24. weeks

  4. Average CPAP Treatment Pressure

    Average treatment pressure during CPAP use, assessed using data downloaded from the CPAP device over the device-data assessment period. Treatment pressure will be reported using the unit provided by the device (cm H2O). Good adherence will be defined as CPAP use for at least 4 hours per night on at least 5 nights per week.

    Measured: 0., and 24. weeks

  5. MIP-MEP measurement

    In centimeters of water (cmH2O), it will be obtained using a Respiratory Muscle Strength Measurement Device-MIP-MEP (MD Diagnostics Ltd., RP Check, United Kingdom) in accordance with the recommendations of the American Thoracic Society.

    Measured: 0.,12., and 24. weeks

  6. Forced Vital Capacity (FVC) measurement

    It is the amount of air expelled after maximum inspiration following a normal breath, expressed in liters. While healthy individuals can forcefully exhale air for 2-3 seconds, this time can be as short as 10-15 seconds for individuals with airway problems. At the end of the test, the expected reference value should be between 80-120%.

    This will be performed using a spirometer (Cosmed, Pony FX, Italy). The best forced vital capacity (FVC) maneuver from at least 3 attempts will be selected according to the criteria of the American Thoracic Society. To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned.

    Measured: 0.,12., and 24. weeks

  7. FEV₁ (Forced Expiratory Volume in 1 Second)

    It is the volume of air exhaled in the first second after forced expiration. Although measured in liters, it actually indicates the airflow rate. In healthy individuals, at least 72% of the air should be exhaled, reflecting the function of the large airways.

    This will be performed using a spirometer (Cosmed, Pony FX, Italy). To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned.

    Measured: 0.,12., and 24. weeks

  8. FEV1/FVC ratio

    This ratio is obtained by dividing FEV1 by FVC and evaluates airway patency and lung function. In a normal individual, this ratio is around 70-80%.

    This will be performed using a spirometer (Cosmed, Pony FX, Italy). To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned.

    Measured: 0.,12., and 24. weeks

  9. FEF 25%-75% (Maximal Mid-Expiratory Flow Rate

    It refers to the average airflow rate during forced expiration, when 25% to 75% of the volume is expelled. It is measured in liters per second. It reflects the function of the medium and small airways. A value above 80% of the reference value is normal.

    This will be performed using a spirometer (Cosmed, Pony FX, Italy). To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned.

    Measured: 0.,12., and 24. weeks

  10. Baecke Habitual Physical Activity Questionnaire (BHPAQ)

    The Baecke Habitual Physical Activity Questionnaire (BHPAQ) is a 16-item self-report questionnaire assessing habitual physical activity over the previous 12 months across three domains: occupational physical activity (8 items), sports physical activity (4 items), and leisure-time physical activity (4 items). The total score is calculated by summing the scores of the three domains. The total score ranges from 3 to 15, with higher scores indicating higher levels of habitual physical activity and a better outcome.

    Measured: 0.,12., and 24. weeks

Secondary outcomes (11)
  1. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    The IPAQ-SF is a self-report questionnaire that assesses vigorous-intensity physical activity, moderate-intensity physical activity, walking, and sitting time during the previous 7 days. Total physical activity is calculated as metabolic equivalent of task minutes per week (MET-minutes/week) by summing the MET-minutes/week derived from walking, moderate-intensity, and vigorous-intensity physical activity. The total physical activity score has no fixed upper limit. Higher scores indicate higher levels of physical activity and a better outcome. Participants may also be classified into low, moderate, or high physical activity categories according to the IPAQ scoring protocol.

    Measured: 0. week

  2. Insomnia Severity Index (ISI)

    7-item self-report questionnaire assessing insomnia severity and its impact on daily functioning. Total scores range from 0 to 28, with higher scores indicating more severe insomnia symptoms.

    Measured: 0.,12., and 24. weeks

  3. Epworth Sleepiness Scale (ESS)

    An 8-item self-report questionnaire assessing the likelihood of dozing during daily activities. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. Scores above 10 suggest excessive daytime sleepiness.

    Measured: 0.,12., and 24. weeks

  4. Functional Outcomes of Sleep Questionnaire-Short Form (FOSQ-10)

    A 10-item self-report questionnaire assessing the impact of sleepiness on daily activities, productivity, activity level, social functioning, and intimate relationships. Total scores range from 5 to 20, with higher scores indicating better functional status.

    Measured: 0.,12., and 24. weeks

  5. Subjective Sleepiness and Sleep Quality

    Subjective sleepiness will be assessed three times daily (09:00, 12:00, and 20:00) using a 0-10 visual analogue scale (VAS), with higher scores indicating greater sleepiness. Subjective sleep quality will be assessed daily upon awakening using a 0-10 VAS, with higher scores indicating better sleep quality.

    Measured: 0.,12., and 24. weeks

  6. Chalder Fatigue Scale (CFS)

    The Chalder Fatigue Scale (CFS) is an 11-item scale developed to assess the severity of fatigue in adults in clinical and research settings. Each item is rated on a 4-point Likert scale, with responses ranging from "better than usual" to "much worse than usual." The total score is calculated using the bimodal scoring method (0-0-1-1), yielding a total score ranging from 0 to 11. Higher scores indicate greater fatigue severity and a worse outcome.

    Measured: 0.,12., and 24. weeks

  7. Hospital Anxiety and Depression Scale (HADS)

    A 14-item self-report questionnaire assessing anxiety and depression symptoms, with separate 7-item subscales. Each subscale is scored from 0 to 21, with higher scores indicating greater symptom severity. Turkish cut-off scores are 10 for anxiety and 7 for depression.

    Measured: 0.,12., and 24. weeks

  8. Short Form Health Survey (SF-12)

    A 12-item questionnaire assessing health-related quality of life across physical and mental health domains. Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores range from 0 to 100, with higher scores indicating better health status.

    Measured: 0.,12., and 24. weeks

  9. Quadriceps Isometric Muscle Strength

    Unilateral isometric knee extension strength will be measured using a handheld dynamometer. Participants will sit with their hips and knees flexed at 90°. Three trials will be performed on each side, and the highest value will be recorded in kilogram-force (kgf).

    Measured: 0.,12., and 24. weeks

  10. Handgrip Strength

    Dominant handgrip strength will be measured using a Jamar hydraulic hand dynamometer. Participants will sit upright with the elbow flexed at 90° and the forearm in a neutral position. Three trials will be performed with 2-minute rest intervals, and the highest value will be recorded.

    Measured: 0.,12., and 24. weeks

  11. Physical Activity Diary

    Participants will record their daily physical activities, including activity type, duration, and perceived exertion, to monitor adherence to physical activity recommendations throughout the study.

    Measured: 0.,12., and 24. weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start23 Oct 2026
  3. Primary completion15 Jun 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07889154
Sponsor's protocol ID
E-10840098-202.3.02-7574
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
27 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Education in people with Obstructive Sleep Apnea and Sleep Quality, run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gülay Aras Bayram, PhD (+905054966284, garas@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (PSQI) (time frame: 0.,12., and 24. weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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