The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome

September 9, 2021 updated by: Zeynep KAÇAR, Istanbul University - Cerrahpasa (IUC)
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 56 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital Capacity
Time Frame: 8 weeks
Vital capacity will be measured in liters, which is one of the respiratory functions.
8 weeks
Functional Exercise Capacity
Time Frame: 8 weeks
It will be evaluated by the 6-minute walking test.
8 weeks
Dyspnoea
Time Frame: 8 weeks
The resting dyspnea level will be evaluated according to the Modified Borg Scale.
8 weeks
fatigue
Time Frame: 8 weeks
Fatigue level will be assessed using the Fatigue Severity Scale (FSS).
8 weeks
Anxiety and Depression Status
Time Frame: 8 weeks
It will be evaluated with the Hospital Anxiety Depression Scale.
8 weeks
Physical Activity Level
Time Frame: 8 weeks
It will be evaluated with the International Physical Activity Questionnaire-Short form (IPAQ-S).
8 weeks
Cognitive Function
Time Frame: 8 weeks
Cognitive evaluation of the patients will be made with the Montreal Cognitive Assessment Scale (MOCA).
8 weeks
Daily Life Activities
Time Frame: 8 weeks
Daily life activities will be evaluated with the London Chest Daily Living Activities Scale.
8 weeks
Daytime Sleepiness
Time Frame: 8 weeks
Daytime sleepiness will be assessed with the Epworth Sleepiness Scale (ESS).
8 weeks
Sleep Quality
Time Frame: 8 weeks
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI).
8 weeks
Life Quality
Time Frame: 8 weeks
Quality of life will be evaluated with the SF-36 scale.
8 weeks
Inspiratory Muscle Strength
Time Frame: 8 weeks
Inspiratory muscle strength will be evaluated by measuring the maximum inspiratory pressure (MIP) in cmH2O.
8 weeks
Forced Vital Capacity
Time Frame: 8 weeks
Forced Vital Capacity will be measured in liters, which is one of the respiratory functions.
8 weeks
Expiratory Muscle Strength
Time Frame: 8 weeks
Expiratory muscle strength will be evaluated by measuring the maximum expiratory pressure (MIP) in cmH2O.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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