Obstructive Sleep Apnea SyndromeNCT04632147
The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome
A study testing Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama in people with Obstructive Sleep Apnea Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Study was planned to investigate the effect of pranayama on dyspnea, daytime sleepiness, cognitive function, quality of life, activities of daily living, functional exercise capacity, physical activity level, sleep quality, fatigue, musculoskeletal pain, depression and anxiety in OSAS. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2021to 25 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with mild to moderate obstructive sleep apnea syndrome.
Who cannot join
- Using a mandibular advancement device
- Regularly using hypnotic drugs
- Have a metabolic disease (eg diabetes, hypothyroidism, obesity)
- Have Hypertension
- Have Malignancy
- Have Epilepsy
Show all 11Show fewer
- Have Heart failure
- Have COPD
- Have asthma
- Neurological, psychological, cooperative problems
- Having a history of maxillofacial surgery
Trial locations and contacts
1 site in 1 country.
About this study
Study was planned to investigate the effect of pranayama on dyspnea, daytime sleepiness, cognitive function, quality of life, activities of daily living, functional exercise capacity, physical activity level, sleep quality, fatigue, musculoskeletal pain, depression and anxiety in OSAS.
Read the detailed description
Thirty-four OSAS patients meeting the inclusion criteria will be randomized into 2 groups as pranayama and control groups. The pranayama group will practice pranayama on their own for 8 weeks, 7 days a week, 3 times a day for 15 minutes. In addition, he will perform a single 15-minute session 3 days a week online under the supervision of a physiotherapist. The control group will not receive any intervention. Dyspnea sensation before and after the training Modified Medical Research Council dyspnea scale, daytime sleepiness Epworth Sleepiness Scale, cognitive function Montreal Cognitive Assessment Scale, quality of life Short Form-36, Turkish Adaptation of Nottingham Health Profile Questionnaire and Functional Outcomes of Sleep Questionnaire, activities of daily living London Chest Activities of Daily Living Scale, functional exercise capacity 30 seconds sit and stand test, physical activity level International Physical Activity Questionnaire-Short Form, sleep quality Pittsburgh Sleep Quality Index, fatigue status Fatigue Severity Scale, depression and anxiety Hospital Anxiety and Depression Scale, musculoskeletal system pain will be assessed with the Nordic Musculoskeletal Questionnaire.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayamaOther
Ujjayi pranayama:It is a pranayamic application that is performed by slightly twisting the throat and breathing through the nose. Nadi shodhana pranayama is breathing alternately through the right and left nostrils.Sukha pranayama is inhaled through the nose for 5 seconds, then given through the nose for 5 seconds. Thus, 6 times of inspiration and expiration is done per minute.
| Study group | Role | What they receive |
|---|---|---|
| Pranayama Group | Experimental | Participants in this group will apply a 45-minute training program at home, consisting of 5 minutes of Ujjayi pranayama, 5 minutes of Nadi-Shodhana pranayama and 5 minutes of Sukha pranayama, 7 days a week for 8 weeks, 3 times a day. In addition, they will perform a 15-minute session 3 day a week for 8 weeks, under the online supervision of a physiotherapist. The training program will last 8 weeks. Receives: Other: Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama |
| Control Group | No intervention | No intervention will be made to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Capacity
Vital capacity will be measured in liters, which is one of the respiratory functions.
Measured: 8 weeks
Functional Exercise Capacity
It will be evaluated by the 6-minute walking test.
Measured: 8 weeks
Dyspnoea
The resting dyspnea level will be evaluated according to the Modified Borg Scale.
Measured: 8 weeks
fatigue
Fatigue level will be assessed using the Fatigue Severity Scale (FSS).
Measured: 8 weeks
Anxiety and Depression Status
It will be evaluated with the Hospital Anxiety Depression Scale.
Measured: 8 weeks
Physical Activity Level
It will be evaluated with the International Physical Activity Questionnaire-Short form (IPAQ-S).
Measured: 8 weeks
Cognitive Function
Cognitive evaluation of the patients will be made with the Montreal Cognitive Assessment Scale (MOCA).
Measured: 8 weeks
Daily Life Activities
Daily life activities will be evaluated with the London Chest Daily Living Activities Scale.
Measured: 8 weeks
Daytime Sleepiness
Daytime sleepiness will be assessed with the Epworth Sleepiness Scale (ESS).
Measured: 8 weeks
Sleep Quality
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI).
Measured: 8 weeks
Life Quality
Quality of life will be evaluated with the SF-36 scale.
Measured: 8 weeks
Inspiratory Muscle Strength
Inspiratory muscle strength will be evaluated by measuring the maximum inspiratory pressure (MIP) in cmH2O.
Measured: 8 weeks
Forced Vital Capacity
Forced Vital Capacity will be measured in liters, which is one of the respiratory functions.
Measured: 8 weeks
Expiratory Muscle Strength
Expiratory muscle strength will be evaluated by measuring the maximum expiratory pressure (MIP) in cmH2O.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start20 Apr 2021
- Primary completion20 Sep 2021 (estimated)
- Study completion25 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants will be randomly divided into two groups as pranayama group and control group.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep KAÇAR, Istanbul University - Cerrahpasa
- Investigators
- Rengin Demir, Study chair, Istanbul University Cerrahpasa Cardiology InstituteÖmer Önder Önder, Study chair, Istanbul Esenyurt University Health Science FacultyErsan Atahan, Study chair, Istanbul University Cerrahpasa Faculty of Medicine Department of Chest Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632147
- Sponsor's protocol ID
- 59491012-604.01.02
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' age, gender, general health status, respiratory functions, functional exercise capacity, dyspnea level, fatigue severity, anxiety and depression status, physical activity level, cognitive function, daily living activities, daytime sleepiness, daily living activities, quality of life, respiratory muscle Data such as strength will be shared with other researchers. Other researchers will be able to obtain these data of the participants both before and after the intervention.
Publications
Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
PubMed 17293726Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Garrod R, Bestall JC, Paul EA, Wedzicha JA, Jones PW. Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL). Respir Med. 2000 Jun;94(6):589-96. doi: 10.1053/rmed.2000.0786.
PubMed 10921765Polkey MI, Green M, Moxham J. Measurement of respiratory muscle strength. Thorax. 1995 Nov;50(11):1131-5. doi: 10.1136/thx.50.11.1131. No abstract available.
PubMed 8553266Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Kacar Akkoc Z, Demir R, Mustafaoglu R, Onder OO, Naci B, Atahan E. The impact of home-based telerehabilitation pranayama on sleep quality and wellbeing in mild to moderate obstructive sleep apnea syndrome. A randomized controlled trial. Biopsychosoc Med. 2026 Apr 16;20(1):11. doi: 10.1186/s13030-026-00359-x.
PubMed 41992331
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT04632147
- Acronym / sponsor ID
- 59491012-604.01.02
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 25 Sep 2021 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study was planned to investigate the effect of pranayama on dyspnea, daytime sleepiness, cognitive function, quality of life, activities of daily living, functional exercise capacity, physical activity level, sleep quality, fatigue, musculoskeletal pain, depression and anxiety in OSAS.
Detailed description
Thirty-four OSAS patients meeting the inclusion criteria will be randomized into 2 groups as pranayama and control groups. The pranayama group will practice pranayama on their own for 8 weeks, 7 days a week, 3 times a day for 15 minutes. In addition, he will perform a single 15-minute session 3 days a week online under the supervision of a physiotherapist. The control group will not receive any intervention. Dyspnea sensation before and after the training Modified Medical Research Council dyspnea scale, daytime sleepiness Epworth Sleepiness Scale, cognitive function Montreal Cognitive Assessment Scale, quality of life Short Form-36, Turkish Adaptation of Nottingham Health Profile Questionnaire and Functional Outcomes of Sleep Questionnaire, activities of daily living London Chest Activities of Daily Living Scale, functional exercise capacity 30 seconds sit and stand test, physical activity level International Physical Activity Questionnaire-Short Form, sleep quality Pittsburgh Sleep Quality Index, fatigue status Fatigue Severity Scale, depression and anxiety Hospital Anxiety and Depression Scale, musculoskeletal system pain will be assessed with the Nordic Musculoskeletal Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups as pranayama group and control group.
| Arm | Type | Receives |
|---|---|---|
| Pranayama Group | Experimental | Other: Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayamaParticipants in this group will apply a 45-minute training program at home, consisting of 5 minutes of Ujjayi pranayama, 5 minutes of Nadi-Shodhana pranayama and 5 minutes of Sukha pranayama, 7 days a week for 8 weeks, 3 times a day. In addition, they will perform a 15-minute session 3 day a week for 8 weeks, under the online supervision of a physiotherapist. The training program will last 8 weeks. |
| Control Group | No intervention | –No intervention will be made to this group. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with mild to moderate obstructive sleep apnea syndrome.
Key exclusion criteria (11 listed)
- Using a mandibular advancement device
- Regularly using hypnotic drugs
- Have a metabolic disease (eg diabetes, hypothyroidism, obesity)
- Have Hypertension
- Have Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayamaUjjayi pranayama:It is a pranayamic application that is performed by slightly twisting the throat and breathing through the nose. Nadi shodhana pranayama is breathing alternately through the right and left nostrils.Sukha pranayama is inhaled through the nose for 5 seconds, then given through the nose for 5 seconds. Thus, 6 times of inspiration and expiration is done per minute. | Other | Pranayama Group |
Primary outcome
Vital Capacity
Time frame: 8 weeks
Vital capacity will be measured in liters, which is one of the respiratory functions.
Functional Exercise Capacity
Time frame: 8 weeks
It will be evaluated by the 6-minute walking test.
Dyspnoea
Time frame: 8 weeks
The resting dyspnea level will be evaluated according to the Modified Borg Scale.
fatigue
Time frame: 8 weeks
Fatigue level will be assessed using the Fatigue Severity Scale (FSS).
Anxiety and Depression Status
Time frame: 8 weeks
It will be evaluated with the Hospital Anxiety Depression Scale.
Physical Activity Level
Time frame: 8 weeks
It will be evaluated with the International Physical Activity Questionnaire-Short form (IPAQ-S).
Cognitive Function
Time frame: 8 weeks
Cognitive evaluation of the patients will be made with the Montreal Cognitive Assessment Scale (MOCA).
Daily Life Activities
Time frame: 8 weeks
Daily life activities will be evaluated with the London Chest Daily Living Activities Scale.
Daytime Sleepiness
Time frame: 8 weeks
Daytime sleepiness will be assessed with the Epworth Sleepiness Scale (ESS).
Sleep Quality
Time frame: 8 weeks
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI).
Life Quality
Time frame: 8 weeks
Quality of life will be evaluated with the SF-36 scale.
Inspiratory Muscle Strength
Time frame: 8 weeks
Inspiratory muscle strength will be evaluated by measuring the maximum inspiratory pressure (MIP) in cmH2O.
Forced Vital Capacity
Time frame: 8 weeks
Forced Vital Capacity will be measured in liters, which is one of the respiratory functions.
Expiratory Muscle Strength
Time frame: 8 weeks
Expiratory muscle strength will be evaluated by measuring the maximum expiratory pressure (MIP) in cmH2O.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 17293726Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 10921765Garrod R, Bestall JC, Paul EA, Wedzicha JA, Jones PW. Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL). Respir Med. 2000 Jun;94(6):589-96. doi: 10.1053/rmed.2000.0786.
- Background: PubMed 8553266Polkey MI, Green M, Moxham J. Measurement of respiratory muscle strength. Thorax. 1995 Nov;50(11):1131-5. doi: 10.1136/thx.50.11.1131. No abstract available.
- Results publication: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Derived from this study: PubMed 41992331Kacar Akkoc Z, Demir R, Mustafaoglu R, Onder OO, Naci B, Atahan E. The impact of home-based telerehabilitation pranayama on sleep quality and wellbeing in mild to moderate obstructive sleep apnea syndrome. A randomized controlled trial. Biopsychosoc Med. 2026 Apr 16;20(1):11. doi: 10.1186/s13030-026-00359-x.
- Individual participant dataSharing planned: Yes. Participants' age, gender, general health status, respiratory functions, functional exercise capacity, dyspnea level, fatigue severity, anxiety and depression status, physical activity level, cognitive function, daily living activities, daytime sleepiness, daily living activities, quality of life, respiratory muscle Data such as strength will be shared with other researchers. Other researchers will be able to obtain these data of the participants both before and after the intervention.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rengin Demir study chair
Istanbul University Cerrahpasa Cardiology Institute
Ömer Önder Önder study chair
Istanbul Esenyurt University Health Science Faculty
Ersan Atahan study chair
Istanbul University Cerrahpasa Faculty of Medicine Department of Chest Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama in people with Obstructive Sleep Apnea Syndrome, 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 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Capacity (time frame: 8 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632147, which also lists 7 linked publications.
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 16 Sep 2021.