NCT07634029

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

May 31, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Obstructive Sleep Apneaexercise trainingcircadian rhythmexercise snacks

Outcome Measures

Primary Outcomes (9)

  • 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.

    From baseline to the end of the intervention at 8 weeks

  • Epworth Sleepiness Scale (ESS) Total Score

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

    From baseline to the end of the intervention at 8 weeks

  • 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.

    From baseline to the end of the intervention at 8 weeks

  • Serum Cortisol Level

    Fasting morning serum cortisol concentration measured by chemiluminescent immunoassay.

    From baseline to the end of the intervention at 8 weeks

  • Serum Thyroid-Stimulating Hormone (TSH) Level

    Fasting morning serum TSH concentration measured by chemiluminescent immunoassay.

    From baseline to the end of the intervention at 8 weeks

  • 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.

    From baseline to the end of the intervention at 8 weeks

  • 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.

    From baseline to the end of the intervention at 8 weeks

  • 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.

    From baseline to the end of the intervention at 8 weeks

  • 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 (%).

    From baseline to the end of the intervention at 8 weeks

Secondary Outcomes (13)

  • Insomnia Severity

    From baseline to the end of the intervention at 8 weeks

  • Waist Circumference (cm)

    From baseline to the end of the intervention at 8 weeks

  • Hip Circumference (cm)

    From baseline to the end of the intervention at 8 weeks

  • Neck Circumference (cm)

    From baseline to the end of the intervention at 8 weeks

  • Muscle Mass (kg)

    From baseline to the end of the intervention at 8 weeks

  • +8 more secondary outcomes

Study Arms (3)

Aerobic Exercise Group

ACTIVE COMPARATOR

Aerobic Exercise Training

Behavioral: Aerobic Exercise Training

Exercise Snacks Group

EXPERIMENTAL

Exercise Snacking

Behavioral: Exercise Snacking

Control Group (Usual Care)

NO INTERVENTION

Usual Care

Interventions

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.

Aerobic Exercise Group

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.

Exercise Snacks Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavior

Study Officials

  • MELİS USUL

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Gökşen Kuran Aslan, Professor

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR
  • Esen Kıyan, Professor

    Istanbul University Faculty of Medicine

    STUDY CHAIR
  • Zeynep Banu Güngör, Professor

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Central Study Contacts

Melis Usul, PhD student

CONTACT

Gökşen Kuran Aslan, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2026

First Posted

June 8, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations