The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Other: Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Türkiye
    • Istanbul, Türkiye, Turkey, 3451
      • Zeynep Kaçar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Control Group; No intervention will be made to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: 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

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Anticipated): September 20, 2021
• Study Completion (Anticipated): September 25, 2021

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: 59491012-604.01.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No