Clinical trial NCT04632147: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into two groups as pranayama group and control group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vital Capacity
timeFrame: 8 weeks
measure: Functional Exercise Capacity
timeFrame: 8 weeks
measure: Dyspnoea
timeFrame: 8 weeks
measure: fatigue
timeFrame: 8 weeks
measure: Anxiety and Depression Status
timeFrame: 8 weeks
measure: Physical Activity Level
timeFrame: 8 weeks
measure: Cognitive Function
timeFrame: 8 weeks
measure: Daily Life Activities
timeFrame: 8 weeks
measure: Daytime Sleepiness
timeFrame: 8 weeks
measure: Sleep Quality
timeFrame: 8 weeks
measure: Life Quality
timeFrame: 8 weeks
measure: Inspiratory Muscle Strength
timeFrame: 8 weeks
measure: Forced Vital Capacity
timeFrame: 8 weeks
measure: Expiratory Muscle Strength
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kaçar
state: Türkiye
Study officials:
affiliation: Istanbul University Cerrahpasa Cardiology Institute
name: Rengin Demir
role: STUDY_CHAIR
affiliation: Istanbul Esenyurt University Health Science Faculty
name: Ömer Önder Önder
role: STUDY_CHAIR
affiliation: Istanbul University Cerrahpasa Faculty of Medicine Department of Chest Diseases
name: Ersan Atahan
role: STUDY_CHAIR
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