Efficacy of Shitali Respiratory Rehabilitation Program in Obstructive Sleep Apnea

November 28, 2024 updated by: Ali Mohamed Ali ismail, Cairo University
obstructive sleep apnea has a negative impact on blood pressure of patients, sleeping quality, and respiration

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

in this study, patients (n=40) with obstructive sleep apnea will participate in this study to be divided in to group I and group II with an equal number of patients (n = 20 for the group). Group I will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, the other group, Group II, will act as control group.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:
        • Principal Investigator:
          • Ali MA Ismail, Lecturer
        • Contact:

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • non-obese patients
  • obstructive sleep apnea (mild and moderate form)

Exclusion Criteria:

  • cardiac patients metabolic diseases kidney diseases

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group I
in this group, patients (n=20) with obstructive sleep apnea will participate and will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance,
Behavioral: shitali pranayama respiratory rehabilitation training
in this group, patients (n=20) with obstructive sleep apnea will participate and will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance
No Intervention: Group II
in this group, patients (n=20) with obstructive sleep apnea will participate and will act as control group. In this group, no intervention will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnea hypopnea index
Time Frame: it will be assessed after 12 weeks
it will be measured through a sleep study
it will be assessed after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic blood pressure
Time Frame: it will be assessed after 12 weeks
it will be assessed via a sphygmomnamoeter
it will be assessed after 12 weeks
diastolic blood pressure
Time Frame: it will be assessed after 12 weeks
it will be assessed via a sphygmomnamoeter
it will be assessed after 12 weeks
Pittsburg sleep quality index
Time Frame: it will be assessed after 12 weeks
it will assess sleep quality
it will be assessed after 12 weeks
respiratory rate
Time Frame: it will be assessed after 12 weeks
it will assess respiratory cycle per minute
it will be assessed after 12 weeks
Epworth sleepiness scale
Time Frame: it will be assessed after 12 weeks
it ill assess daytime sleepiness
it will be assessed after 12 weeks
visual analogue scale of by-partner reported sleep difficulty
Time Frame: it will be measured after 12 weeks
it will assess by-partner reported sleep difficulty due to snoring of patient
it will be measured after 12 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali Ismail, lecturer, Cairo University

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)

November 7, 2024

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014233-15

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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