The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04632147
• Other study ID #: 59491012-604.01.02
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: September 25, 2021

Study information

• Verified date: September 2021
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: September 25, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Zeynep Kaçar	Istanbul	Türkiye

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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

Craig CL, Marshall AL, Sjöström 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. — View 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. — View Citation

Nasreddine ZS, Phillips NA, Bédirian 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. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

Polkey MI, Green M, Moxham J. Measurement of respiratory muscle strength. Thorax. 1995 Nov;50(11):1131-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital Capacity	Vital capacity will be measured in liters, which is one of the respiratory functions.	8 weeks
Primary	Functional Exercise Capacity	It will be evaluated by the 6-minute walking test.	8 weeks
Primary	Dyspnoea	The resting dyspnea level will be evaluated according to the Modified Borg Scale.	8 weeks
Primary	fatigue	Fatigue level will be assessed using the Fatigue Severity Scale (FSS).	8 weeks
Primary	Anxiety and Depression Status	It will be evaluated with the Hospital Anxiety Depression Scale.	8 weeks
Primary	Physical Activity Level	It will be evaluated with the International Physical Activity Questionnaire-Short form (IPAQ-S).	8 weeks
Primary	Cognitive Function	Cognitive evaluation of the patients will be made with the Montreal Cognitive Assessment Scale (MOCA).	8 weeks
Primary	Daily Life Activities	Daily life activities will be evaluated with the London Chest Daily Living Activities Scale.	8 weeks
Primary	Daytime Sleepiness	Daytime sleepiness will be assessed with the Epworth Sleepiness Scale (ESS).	8 weeks
Primary	Sleep Quality	Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI).	8 weeks
Primary	Life Quality	Quality of life will be evaluated with the SF-36 scale.	8 weeks
Primary	Inspiratory Muscle Strength	Inspiratory muscle strength will be evaluated by measuring the maximum inspiratory pressure (MIP) in cmH2O.	8 weeks
Primary	Forced Vital Capacity	Forced Vital Capacity will be measured in liters, which is one of the respiratory functions.	8 weeks
Primary	Expiratory Muscle Strength	Expiratory muscle strength will be evaluated by measuring the maximum expiratory pressure (MIP) in cmH2O.	8 weeks