The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome
1 other identifier
interventional
34
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 17, 2020
CompletedStudy Start
First participant enrolled
April 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2021
CompletedSeptember 16, 2021
September 1, 2021
5 months
October 22, 2020
September 9, 2021
Conditions
Outcome Measures
Primary Outcomes (14)
Vital Capacity
Vital capacity will be measured in liters, which is one of the respiratory functions.
8 weeks
Functional Exercise Capacity
It will be evaluated by the 6-minute walking test.
8 weeks
Dyspnoea
The resting dyspnea level will be evaluated according to the Modified Borg Scale.
8 weeks
fatigue
Fatigue level will be assessed using the Fatigue Severity Scale (FSS).
8 weeks
Anxiety and Depression Status
It will be evaluated with the Hospital Anxiety Depression Scale.
8 weeks
Physical Activity Level
It will be evaluated with the International Physical Activity Questionnaire-Short form (IPAQ-S).
8 weeks
Cognitive Function
Cognitive evaluation of the patients will be made with the Montreal Cognitive Assessment Scale (MOCA).
8 weeks
Daily Life Activities
Daily life activities will be evaluated with the London Chest Daily Living Activities Scale.
8 weeks
Daytime Sleepiness
Daytime sleepiness will be assessed with the Epworth Sleepiness Scale (ESS).
8 weeks
Sleep Quality
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI).
8 weeks
Life Quality
Quality of life will be evaluated with the SF-36 scale.
8 weeks
Inspiratory Muscle Strength
Inspiratory muscle strength will be evaluated by measuring the maximum inspiratory pressure (MIP) in cmH2O.
8 weeks
Forced Vital Capacity
Forced Vital Capacity will be measured in liters, which is one of the respiratory functions.
8 weeks
Expiratory Muscle Strength
Expiratory muscle strength will be evaluated by measuring the maximum expiratory pressure (MIP) in cmH2O.
8 weeks
Study Arms (2)
Pranayama Group
EXPERIMENTALParticipants 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 INTERVENTIONNo intervention will be made to this group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with mild to moderate obstructive sleep apnea syndrome.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zeynep Kaçar
Istanbul, Türkiye, 3451, Turkey (Türkiye)
Related Publications (6)
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.
PMID: 17293726BACKGROUNDCraig 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.
PMID: 12900694BACKGROUNDNasreddine 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.
PMID: 15817019BACKGROUNDGarrod 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.
PMID: 10921765BACKGROUNDPolkey 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.
PMID: 8553266BACKGROUNDBorg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PMID: 7154893RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rengin Demir
Istanbul University Cerrahpasa Cardiology Institute
- STUDY CHAIR
Ömer Önder Önder
Istanbul Esenyurt University Health Science Faculty
- STUDY CHAIR
Ersan Atahan
Istanbul University Cerrahpasa Faculty of Medicine Department of Chest Diseases
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
- physiotherapist
Study Record Dates
First Submitted
October 22, 2020
First Posted
November 17, 2020
Study Start
April 20, 2021
Primary Completion
September 20, 2021
Study Completion
September 25, 2021
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- starting 6 months after publication
- Access Criteria
- IPD will be shared with all researchers in the study.
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.