The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome

Not Applicable

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Other: Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama

• Registration Number: NCT04632147
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-17
• Study Start: 2021-04-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-16
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pranayama Group	Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Zeynep Kaçar; 🇹🇷 Istanbul, Türkiye, Turkey