Polycystic Ovarian Syndrome (PCOS)NCT07698925
Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome
A study testing Diaphragmatic breathing exercises and Lifestyle modification advices in people with Polycystic Ovarian Syndrome (PCOS) and Pittsburg Sleep Quality Index, run by Adly A Adam at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS), Pittsburg Sleep Quality Index, Fatigue Severity Scale
- What is being tested?
- Diaphragmatic breathing exercises and Lifestyle modification advices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University; Faculty of Physical Therapy
Cairo, Cairo Governorate, 11432
Naira H Mohamed, B.Sc., 01287797493 ext. 010, dradnanpts@gmail.com
Mai A Shehata, PHD, 01287797493 ext. 105, nairahesham083@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovarian Syndrome (PCOS), Pittsburg Sleep Quality Index, Fatigue Severity Scale, Insomnia Severity Index, Diaphragmatic Breathing Exercise, Sleep Disorders
- Being tested
- Diaphragmatic breathing exercises, Lifestyle modification advices
- Keywords
- Polycystic ovary syndrome, Diaphragmatic breathing exercises, Sleep disorders, Pittsburg sleep quality index, Insomnia severity index, Fatigue severity scale
- Medical subject headings
- Polycystic Ovary Syndrome, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing exercisesOther
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 advicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group A (Diaphragmatic breathing group) | Experimental | 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 Receives: Other: Diaphragmatic breathing exercises; Other: Lifestyle modification advices |
| Control Group B (Lifestyle modification advices group) | Active comparator | 27 participants with sleep disorders related to polycystic ovarian syndrome. They will receive lifestyle modification advices only as group (A) for 8 weeks Receives: Other: Lifestyle modification advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
Secondary outcomes (2)
Insomnia Severity Index (ISI)
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.
Measured: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
Fatigue Assessment Scale (FAS)
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
Measured: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start11 Jul 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Soheir M Elkosery, Professor, Study chair, Cairo University; Faculty of Physical TherapyAhmed M Othman, Professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698925
- Sponsor's protocol ID
- P.T.REC/012/005971
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07698925
- Acronym / sponsor ID
- P.T.REC/012/005971
- Conditions
- Polycystic Ovarian Syndrome (PCOS), Pittsburg Sleep Quality Index, Fatigue Severity Scale, Insomnia Severity Index, Diaphragmatic Breathing Exercise, Sleep Disorders
- Keywords
- Polycystic ovary syndrome, Diaphragmatic breathing exercises, Sleep disorders, Pittsburg sleep quality index, Insomnia severity index, Fatigue severity scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Adly A AdamUniversity, hospital or other
- Study start
- 11 Jul 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Study group A (Diaphragmatic breathing group) | Experimental | Other: Diaphragmatic breathing exercises, Other: Lifestyle modification advices27 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 |
| Control Group B (Lifestyle modification advices group) | Active comparator | Other: Lifestyle modification advices27 participants with sleep disorders related to polycystic ovarian syndrome. They will receive lifestyle modification advices only as group (A) for 8 weeks |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged from 25-35 years old, Diagnosed with PCOS by gynecologist, diagnosis of PCOS will be based on the 2003 Rotterdam criteria.
Key exclusion criteria (6 listed)
- • Women with autoimmune diseases and cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic breathing exercisesIts 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 | Study group A (Diaphragmatic breathing group) |
| Lifestyle modification advicesAvoid 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. | Other | Control Group B (Lifestyle modification advices group), Study group A (Diaphragmatic breathing group) |
Primary outcome
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.
2 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soheir M Elkosery, Professor study chair
Cairo University; Faculty of Physical Therapy
Ahmed M Othman, Professor study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing exercises and Lifestyle modification advices in people with Polycystic Ovarian Syndrome (PCOS) and Pittsburg Sleep Quality Index, run by Adly A Adam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naira H Mohamed, B.Sc (01287797493 ext. 010, nairahesham083@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.