Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

July 12, 2026 updated by: Adly A Adam

Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome

Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder in females in reproductive age and not completely understood. Women with PCOS appear to have an increased frequency of sleep problems. Diaphragmatic Breathing (DB) exercises has positive effects on improving sleep quality. The purpose of this study will evaluate the effect of diaphragmatic breathing exercises on improving sleep quality in polycystic ovarian syndrome women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Polycystic ovary syndrome (PCOS) is one of the most prevalent metabolic and reproductive disorders impacting women of reproductive age. Difficulty falling asleep and maintaining sleep has been reported among women with PCOS. Taken together, these data suggest that women with PCOS are at an increased risk for sleep disturbances, obesity and depression are associated with the increased risk. Pharmacotherapy is only recommended for the short term. This is particularly pertinent for women with PCOS whose insomnia and other sleep disturbances are unlikely to be short term and are related to underlying factors that need to be addressed directly. So, there is an urgent need to a safe method for PCOS women such as diaphragmatic breathing that need further more investigations which will be conducted in this study.

Study Type

Interventional

Enrollment (Estimated)

54

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
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11432
        • Recruiting
        • Cairo University; Faculty of Physical Therapy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naira H Mohamed, B.Sc

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:

  • Women aged from 25-35 years old, Diagnosed with PCOS by gynecologist, diagnosis of PCOS will be based on the 2003 Rotterdam criteria.

    • They have a Pittsburgh sleep quality index (PSQI) score greater than 5.
    • Not participating in any physical exercise for the previous 3 months.
    • They have an insomnia severity index score greater than 15.
    • They have a fatigue severity scale score greater than 36.
    • Ability to use internet and phone services

Exclusion Criteria:

  • • Women with autoimmune diseases and cancer.

    • Women with neurological, mental, cardiopulmonary and musculoskeletal disorders.
    • Pregnant or lactating women.
    • Women who showed regular adherence to sleeping pills, antidepressants and hormonal replacement agents.
    • Inability to perform diaphragmatic breathing due to physical limitations.
    • Women who participate or receive any interventions that could affect their sleep

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group A (Diaphragmatic breathing group)
27 participants with sleep disorders related to polycystic ovarian syndrome. They will receive diaphragmatic breathing exercises three times per week, for 6 minutes twice a day and will receive lifestyle modification advices for 8 weeks
Other: Diaphragmatic breathing exercises
Its course is 3 times per week, 6 minutes twice a day, for 8 weeks. When it's the first time to learn how to perform the diaphragmatic breathing technique, it's easier to follow the instructions lying down in supine position with a pillow under head. The patient will be asked to place one hand on her abdomen, just below her ribcage, and the other hand on the middle of her chest to become aware of her diaphragm's position and function during breathing. She will be told to breathe slowly and deeply through her nose and let her abdomen rise as much as possible. The length of the inhalation or exhalation should be 2-3 seconds
Other: Lifestyle modification advices
Avoid caffeine, smoking, alcohol, napping; thirsty or hungry Regular exercising, sleep timing, relax techniques; Reduce noise, Ensure bedroom clean, no TV, mobile in bed, snack near bed, warm bath pre sleep, wear sleep cloths, most relaxed position for sleep.
Active Comparator: Control Group B (Lifestyle modification advices group)
27 participants with sleep disorders related to polycystic ovarian syndrome. They will receive lifestyle modification advices only as group (A) for 8 weeks
Other: Lifestyle modification advices
Avoid caffeine, smoking, alcohol, napping; thirsty or hungry Regular exercising, sleep timing, relax techniques; Reduce noise, Ensure bedroom clean, no TV, mobile in bed, snack near bed, warm bath pre sleep, wear sleep cloths, most relaxed position for sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
a reliable, valid, standardized measure of sleep quality, discriminate "good" and "poor" sleepers and provide an easy index for patients to complete. It's classified into seven subcategories: "subjective sleep quality" (1 item), "sleep latency" (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (7 items), use of sleeping medication (1 item), and daytime dysfunction (3 items). Five additional questions rated by the respondent's roommate or bed partner are included for clinical purposes and are not scored, all seven-item scores were added together to generate a total score ranging from 0 to 21.
Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
A brief measure with only seven items, easily administered, All seven items are scored from 0 to 4, where higher scores indicate increasing severity of sleep disturbances and associated daytime symptoms, all seven-item scores were added together to generate a total score ranging from 0 to 28. The ISI has been translated into multiple languages, validated in 12 countries and as a web-based measurement.
Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
Fatigue Assessment Scale (FAS)
Time Frame: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
A 10-item self-reported scale evaluating symptoms of chronic fatigue, it measures both physical and mental symptoms. Each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. Since its introduction, the FAS was used in 26 different diseases or conditions, Its reliability and validity have proved to be good, the FAS is available in 20 languages and widely used
Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.

Collaborators and Investigators

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

Sponsor

Adly A Adam

Investigators

  • Study Chair: Soheir M Elkosery, Professor, Cairo University; Faculty of Physical Therapy
  • Study Director: Ahmed M Othman, Professor, Tanta 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)

July 11, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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