The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome

NCT ID: NCT04632147

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2021-09-25

Brief Summary

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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

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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

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly divided into two groups as pranayama group and control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pranayama Group

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.

Group Type EXPERIMENTAL

Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama

Intervention Type OTHER

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.

Control Group

No intervention will be made to this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with mild to moderate obstructive sleep apnea syndrome.

Exclusion Criteria

* Using a mandibular advancement device
* Regularly using hypnotic drugs
* Have a metabolic disease (eg diabetes, hypothyroidism, obesity)
* Have Hypertension
* Have Malignancy
* Have Epilepsy
* Have Heart failure
* Have COPD
* Have asthma
* Neurological, psychological, cooperative problems
* Having a history of maxillofacial surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Zeynep KAÇAR

physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rengin Demir

Role: STUDY_CHAIR

Istanbul University Cerrahpasa Cardiology Institute

Ömer Önder Önder

Role: STUDY_CHAIR

Istanbul Esenyurt University Health Science Faculty

Ersan Atahan

Role: STUDY_CHAIR

Istanbul University Cerrahpasa Faculty of Medicine Department of Chest Diseases

Locations

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Zeynep Kaçar

Istanbul, Türkiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 17293726 (View on PubMed)

Craig 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.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

Nasreddine 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.

Reference Type BACKGROUND
PMID: 15817019 (View on PubMed)

Garrod 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.

Reference Type BACKGROUND
PMID: 10921765 (View on PubMed)

Polkey 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.

Reference Type BACKGROUND
PMID: 8553266 (View on PubMed)

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

Reference Type RESULT
PMID: 7154893 (View on PubMed)

Other Identifiers

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59491012-604.01.02

Identifier Type: -

Identifier Source: org_study_id

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