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Obstructive Sleep Apnea (OSA)NCT07634029

Exercise Interventions in Obstructive Sleep Apnea Syndrome

A study testing Aerobic Exercise Training and Exercise Snacking in people with Obstructive Sleep Apnea (OSA) and Exercise Snacks, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Obstructive Sleep Apnea Syndrome (OSA) is a condition characterized by repeated pauses or reductions in breathing during sleep, which can negatively affect sleep quality, daytime functioning, and physical capacity. Read more about this study

Who is it for?
Ages 30 to 65 years
What is being tested?
Aerobic Exercise Training and Exercise Snacking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2026to Feb 2028
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 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals diagnosed with OSAHS (AHI ≥ 15) confirmed by polysomnography, with moderate or severe disease, who have been receiving CPAP therapy for at least 3 months.
  • Adults aged 30-65 years.
  • No participation in any regular exercise program within the last 6 months.

Who cannot join

  • Individuals with OSAHS and a body mass index (BMI) > 35 kg/m²
  • Severe chronic pulmonary disease
  • Neurological or musculoskeletal disorders that prevent exercise
  • Unstable cardiovascular conditions
  • Unstable metabolic conditions
  • Severe psychiatric disorders such as bipolar disorder or schizophrenia
Show all 11Show fewer
  • Pregnancy or breastfeeding
  • Individuals working night shifts or with schedules that may cause jet lag
  • Use of steroid or hormone therapy
  • Use of melatonin or sleep-regulating medications within the last 3 months
  • Presence of acute infection or inflammation

Trial locations and contacts

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

Melis Usul, PhD student contact

+(90)5364667235

melisausul1999@gmail.com

Gökşen Kuran Aslan, Professor contact

+(90)5324095246

goksenkuran@yahoo.com

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye

    Istanbul

    Melis Usul, +(90)5364667235, melisausul1999@gmail.com

    Melis USUL

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Exercise Snacks and Aerobic Exercise on Circadian Rhythm and Functional Capacity in Individuals With Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome (OSA) is a condition characterized by repeated pauses or reductions in breathing during sleep, which can negatively affect sleep quality, daytime functioning, and physical capacity. Although regular exercise is known to have beneficial effects in OSA, the effects of different exercise approaches on circadian rhythm and functional capacity have not been sufficiently investigated.The primary aim of this study is to compare the effects of exercise snacking and aerobic exercise on circadian rhythm and functional capacity in individuals with OSA, in comparison with a control group. The secondary aim is to evaluate the effects of these exercise interventions on peripheral muscle strength, fatigue level, body composition, quality of life, and physical activity level.Participants will be randomly assigned to three groups: an aerobic exercise group, an exercise snacking group, and a control group. While the exercise groups will follow their respective intervention programs, the control group will continue their routine treatment.This study aims to answer whether exercise snacking, which consists of short bouts of exercise distributed throughout the day, may be an alternative or complementary approach to traditional aerobic exercise in individuals with OSA. In addition, this study aims to be the first randomized controlled trial evaluating the effects of exercise snacking on circadian rhythm and functional capacity in individuals with OSA.

Read the detailed description

Obstructive Sleep Apnea Syndrome (OSA) is a common sleep-related breathing disorder characterized by repeated episodes of partial or complete upper airway obstruction during sleep. It is associated with intermittent hypoxia, sleep fragmentation, and increased risk of cardiovascular and metabolic comorbidities. Emerging evidence also suggests a bidirectional relationship between OSA and circadian rhythm disruption, where each condition may negatively influence the other. Therefore, improving circadian regulation may be an important therapeutic target in OSA management.Exercise is a widely accepted non-pharmacological intervention in OSA due to its potential benefits on sleep-related outcomes and overall health. However, adherence to conventional structured exercise programs may be limited due to time constraints and sustainability issues. Recently, exercise snacking-short bouts of exercise performed throughout the day-has been proposed as a time-efficient and more feasible alternative to traditional exercise approaches. This strategy may improve long-term adherence by integrating physical activity into daily routines without requiring supervised sessions.Despite its potential advantages, evidence regarding the effects of exercise snacking in individuals with OSA is currently limited. In addition, there is a lack of randomized controlled trials comparing exercise snacking with aerobic exercise while also evaluating circadian rhythm-related outcomes in this population.This study is designed as a prospective, single-blind, randomized controlled trial. A total of 39 individuals diagnosed with moderate to severe OSA will be randomly assigned to three groups: aerobic exercise group, exercise snacking group, and control group. The intervention period will last 8 weeks. The aerobic exercise group will perform supervised aerobic and resistance-based training, while the exercise snacking group will perform short, home-based exercise bouts distributed across the day. The control group will continue usual medical care and receive a single session of sleep hygiene education.The study will evaluate the effects of the interventions on circadian rhythm and functional capacity as primary outcomes, and on secondary outcomes including fatigue, muscle strength, body composition, physical activity level, insomnia severity, and quality of life. Assessments will be performed at baseline and after the 8-week intervention period.

Being tested
Aerobic Exercise Training, Exercise Snacking
Keywords
Obstructive Sleep Apnea, exercise training, circadian rhythm, exercise snacks
Medical subject headings
Sleep Apnea, Obstructive, Motor Activity

What participants receive

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

  • Aerobic Exercise TrainingBehavioural

    Participants in the aerobic exercise group will undergo an 8-week supervised aerobic exercise program on a cycle ergometer, performed twice per week. Each session will last approximately 30-45 minutes and will include a 5-minute low-intensity warm-up and a 5-minute cool-down period. Exercise intensity will be set at a moderate level according to the Karvonen method. The main exercise duration will be progressively increased throughout the intervention period: 20 minutes during weeks 1-2, 25 minutes during weeks 3-4, 30 minutes during weeks 5-6, and 35 minutes during weeks 7-8. Participants' heart rate will be monitored during exercise sessions, and perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale.In addition, all participants will be instructed to perform resistance exercises once per week. The exercises will target the upper extremity, lower extremity, and core muscles and will consist of three different exercises.

  • Exercise SnackingBehavioural

    The exercises will be performed by participants at home and supervised by the researcher. Since progression of each exercise will be implemented every two weeks, participants will be scheduled to attend the clinic every two weeks, where the exercises will be demonstrated. Each session will consist of six different exercises (squat, heel raises, marching in place, jumping jacks, upright row, and chest press). Each exercise will be performed for 1 minute, followed by a 1-minute seated rest interval. Thus, each session will last approximately 12 minutes. Exercise progression will be applied every two weeks for each exercise. During the sessions, participants will monitor their heart rate and oxygen saturation. An oxygen saturation level below 90% will be defined as the exercise termination criterion. Participants will be provided with a daily logbook to record completion of exercise snacking sessions.

Study groups in NCT07634029
Study groupRoleWhat they receive
Aerobic Exercise GroupActive comparatorAerobic Exercise Training
Receives: Behavioral: Aerobic Exercise Training
Exercise Snacks GroupExperimentalExercise Snacking
Receives: Behavioral: Exercise Snacking
Control Group (Usual Care)No interventionUsual Care

What is being measured

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

  1. Pittsburgh Sleep Quality Index (PSQI) Total Score

    Sleep quality assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: From baseline to the end of the intervention at 8 weeks

  2. Epworth Sleepiness Scale (ESS) Total Score

    Daytime sleepiness will be assessed using the Epworth Sleepiness Scal (ESS).Scores ≥10 indicate excessive daytime sleepiness.

    Measured: From baseline to the end of the intervention at 8 weeks

  3. Morningness-Eveningness Questionnaire (MEQ) Total Score

    Circadian rhythm preference will be assessed using the Morningness-Eveningness Questionnaire (MEQ).The questionnaire consists of 19 items evaluating sleep-wake preferences and chronotype.Higher scores indicate morningness, whereas lower scores indicate eveningness.

    Measured: From baseline to the end of the intervention at 8 weeks

  4. Serum Cortisol Level

    Fasting morning serum cortisol concentration measured by chemiluminescent immunoassay.

    Measured: From baseline to the end of the intervention at 8 weeks

  5. Serum Thyroid-Stimulating Hormone (TSH) Level

    Fasting morning serum TSH concentration measured by chemiluminescent immunoassay.

    Measured: From baseline to the end of the intervention at 8 weeks

  6. Functional Capacity

    Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) according to American Thoracic Society criteria. Walking distance covered within 6 minutes will be recorded in meters. Higher values indicate better functional capacity.

    Measured: From baseline to the end of the intervention at 8 weeks

  7. Total Sleep Time (Sleep Diary)

    Total sleep time will be assessed subjectively using a sleep diary based on the Consensus Sleep Diary (CSD). Participants will complete the diary for 7 consecutive days at baseline and at week 8. Total sleep time will be recorded in minutes.

    Measured: From baseline to the end of the intervention at 8 weeks

  8. Total Sleep Time (Wearable Device)

    Total sleep time will be objectively assessed using a Polar Unite wearable activity tracker with Sleep Plus Stages™ algorithm. Measurements will be collected over 3 consecutive nights at baseline and at week 8. Total sleep time will be expressed in minutes.

    Measured: From baseline to the end of the intervention at 8 weeks

  9. Sleep Efficiency (Wearable Device)

    Sleep efficiency will be assessed using a Polar Unite wearable activity tracker with Sleep Plus Stages™ algorithm. Measurements will be collected over 3 consecutive nights at baseline and at week 8. Sleep efficiency will be expressed as percentage (%).

    Measured: From baseline to the end of the intervention at 8 weeks

Secondary outcomes (13)
  1. Insomnia Severity

    Insomnia severity will be assessed using the Insomnia Severity Index (ISI). The ISI consists of 7 items scored from 0 to 4, with a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity. Scores ≥10 indicate clinically significant insomnia.

    Measured: From baseline to the end of the intervention at 8 weeks

  2. Waist Circumference (cm)

    Waist circumference measured using a non-elastic tape measure.

    Measured: From baseline to the end of the intervention at 8 weeks

  3. Hip Circumference (cm)

    Hip circumference measured using a non-elastic tape measure.

    Measured: From baseline to the end of the intervention at 8 weeks

  4. Neck Circumference (cm)

    Neck circumference measured using a non-elastic tape measure.

    Measured: From baseline to the end of the intervention at 8 weeks

  5. Muscle Mass (kg)

    Muscle mass assessed using bioelectrical impedance analysis (BIA).

    Measured: From baseline to the end of the intervention at 8 weeks

  6. Body Fat Percentage (%)

    Body fat percentage assessed using bioelectrical impedance analysis (BIA).

    Measured: From baseline to the end of the intervention at 8 weeks

  7. Bone Mass (kg)

    Bone mass assessed using bioelectrical impedance analysis (BIA).

    Measured: From baseline to the end of the intervention at 8 weeks

  8. Body Water Percentage (%)

    Body water percentage assessed using bioelectrical impedance analysis (BIA).

    Measured: From baseline to the end of the intervention at 8 weeks

  9. Fatigue Severity

    Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The FSS consists of 9 items scored from 1 to 7. Higher scores indicate greater fatigue severity. Mean scores ≥4 indicate clinically significant fatigue.

    Measured: From baseline to the end of the intervention at 8 weeks

  10. Peripheral Muscle Strength

    Peripheral muscle strength (quadriceps, biceps brachii, and handgrip strength) will be assessed using a hand-held dynamometer and handgrip dynamometer. Higher values indicate greater muscle strength.

    Measured: From baseline to the end of the intervention at 8 weeks

  11. Physical Activity Level

    Physical activity level will be assessed using a pedometer. Average daily step count (steps/day) will be recorded. Higher values indicate greater physical activity.

    Measured: From baseline to the end of the intervention at 8 weeks

  12. Health-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ)

    Quality of life will be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ). The questionnaire consists of 26 items with total scores ranging from 4 to 16. Lower scores indicate greater impairment in sleep-related quality of life.

    Measured: From baseline to the end of the intervention at 8 weeks

  13. Patient Global Impression of Change

    Perceived clinical improvement will be assessed using the Patient Global Impression of Change (PGIC). The scale ranges from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater perceived improvement.

    Measured: At the end of the intervention (8 weeks)

Timeline

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

  1. First posted8 Jun 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionFeb 2028 (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
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07634029
Sponsor's protocol ID
3RQX7PDq
Status last verified
Jun 2026
First submitted
31 May 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise Training and Exercise Snacking in people with Obstructive Sleep Apnea (OSA) and Exercise Snacks, run by Istanbul University - Cerrahpasa 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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Jun 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 Melis Usul, PhD student (+(90)5364667235, melisausul1999@gmail.com), 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) Total Score (time frame: From baseline to the end of the intervention at 8 weeks). The study lists 9 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 8 Jun 2026.

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