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NCT Number: NCT07698925

Diaphragmatic Breathing Exercises on Sleep Disorders un 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.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Diaphragmatic Breathing Exercise Endocrine System Diseases Fatigue Severity Scale Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Insomnia Severity Index Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Pittsburg Sleep Quality Index Polycystic Ovary Syndrome Signs and Symptoms Sleep Disorders Sleep Wake Disorders Urogenital Diseases

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University; Faculty of Physical Therapy

Cairo, Cairo Governorate, 11432, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragmatic breathing exercises

Other

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

Lifestyle modification advices

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Adly A Adam

Other

Registry information

Official study title

Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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