The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome
Eligibility Criteria
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
Sites / Locations
- Zeynep Kaçar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pranayama Group
Control Group
Arm Description
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.
No intervention will be made to this group.
Outcomes
Primary Outcome Measures
Vital Capacity
Vital capacity will be measured in liters, which is one of the respiratory functions.
Functional Exercise Capacity
It will be evaluated by the 6-minute walking test.
Dyspnoea
The resting dyspnea level will be evaluated according to the Modified Borg Scale.
fatigue
Fatigue level will be assessed using the Fatigue Severity Scale (FSS).
Anxiety and Depression Status
It will be evaluated with the Hospital Anxiety Depression Scale.
Physical Activity Level
It will be evaluated with the International Physical Activity Questionnaire-Short form (IPAQ-S).
Cognitive Function
Cognitive evaluation of the patients will be made with the Montreal Cognitive Assessment Scale (MOCA).
Daily Life Activities
Daily life activities will be evaluated with the London Chest Daily Living Activities Scale.
Daytime Sleepiness
Daytime sleepiness will be assessed with the Epworth Sleepiness Scale (ESS).
Sleep Quality
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI).
Life Quality
Quality of life will be evaluated with the SF-36 scale.
Inspiratory Muscle Strength
Inspiratory muscle strength will be evaluated by measuring the maximum inspiratory pressure (MIP) in cmH2O.
Forced Vital Capacity
Forced Vital Capacity will be measured in liters, which is one of the respiratory functions.
Expiratory Muscle Strength
Expiratory muscle strength will be evaluated by measuring the maximum expiratory pressure (MIP) in cmH2O.
Secondary Outcome Measures
Full Information
NCT ID
NCT04632147
First Posted
October 22, 2020
Last Updated
September 9, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04632147
Brief Title
The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome
Official Title
The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Anticipated)
Study Completion Date
September 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly divided into two groups as pranayama group and control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pranayama Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be made to this group.
Intervention Type
Other
Intervention Name(s)
Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vital Capacity
Description
Vital capacity will be measured in liters, which is one of the respiratory functions.
Time Frame
8 weeks
Title
Functional Exercise Capacity
Description
It will be evaluated by the 6-minute walking test.
Time Frame
8 weeks
Title
Dyspnoea
Description
The resting dyspnea level will be evaluated according to the Modified Borg Scale.
Time Frame
8 weeks
Title
fatigue
Description
Fatigue level will be assessed using the Fatigue Severity Scale (FSS).
Time Frame
8 weeks
Title
Anxiety and Depression Status
Description
It will be evaluated with the Hospital Anxiety Depression Scale.
Time Frame
8 weeks
Title
Physical Activity Level
Description
It will be evaluated with the International Physical Activity Questionnaire-Short form (IPAQ-S).
Time Frame
8 weeks
Title
Cognitive Function
Description
Cognitive evaluation of the patients will be made with the Montreal Cognitive Assessment Scale (MOCA).
Time Frame
8 weeks
Title
Daily Life Activities
Description
Daily life activities will be evaluated with the London Chest Daily Living Activities Scale.
Time Frame
8 weeks
Title
Daytime Sleepiness
Description
Daytime sleepiness will be assessed with the Epworth Sleepiness Scale (ESS).
Time Frame
8 weeks
Title
Sleep Quality
Description
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI).
Time Frame
8 weeks
Title
Life Quality
Description
Quality of life will be evaluated with the SF-36 scale.
Time Frame
8 weeks
Title
Inspiratory Muscle Strength
Description
Inspiratory muscle strength will be evaluated by measuring the maximum inspiratory pressure (MIP) in cmH2O.
Time Frame
8 weeks
Title
Forced Vital Capacity
Description
Forced Vital Capacity will be measured in liters, which is one of the respiratory functions.
Time Frame
8 weeks
Title
Expiratory Muscle Strength
Description
Expiratory muscle strength will be evaluated by measuring the maximum expiratory pressure (MIP) in cmH2O.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rengin Demir
Organizational Affiliation
Istanbul University Cerrahpasa Cardiology Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ömer Önder Önder
Organizational Affiliation
Istanbul Esenyurt University Health Science Faculty
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ersan Atahan
Organizational Affiliation
Istanbul University Cerrahpasa Faculty of Medicine Department of Chest Diseases
Official's Role
Study Chair
Facility Information:
Facility Name
Zeynep Kaçar
City
Istanbul
State/Province
Türkiye
ZIP/Postal Code
3451
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
IPD will be shared with all researchers in the study.
Citations:
PubMed Identifier
17293726
Citation
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.
Results Reference
background
PubMed Identifier
12900694
Citation
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.
Results Reference
background
PubMed Identifier
15817019
Citation
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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
10921765
Citation
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.
Results Reference
background
PubMed Identifier
8553266
Citation
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.
Results Reference
background
PubMed Identifier
7154893
Citation
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Results Reference
result
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The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome
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