SLEEP APNEA PREGNANCYNCT06273787
Effect of Diaphragmatic Release in Sleep Quality During Pregnancy
A study testing diaphragmatic release in people with SLEEP APNEA PREGNANCY, run by MTI University at 1 site in Egypt.
Trial summary
Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- SLEEP APNEA PREGNANCY
- What is being tested?
- diaphragmatic release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 17 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women (at third trimester), diagnosed with sleep disordered breathing by the gynaecologist.
- Their ages will range from 30- 40 years old .
- Their BMI will be 25 to 30kg/m2.
- All are multipara.
Who cannot join
- Women will be excluded from the study if they have:
- Previous pulmonary surgery.
- any pulmonary diseases.
- Asthma.
- Neurological disorders
- Musculoskeletal disorders (severe osteoarthritis, osteoporosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Diaphragmatic Release in Sleep Quality During Pregnancy, Randomized Controlled Trail
Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy.
Read the detailed description
The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will provide scientific basis for the clinical application of diaphragmatic release in sleep disordered breathing during pregnancy
- Conditions
- SLEEP APNEA PREGNANCY
- Being tested
- diaphragmatic release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic releaseOther
diaphragmatic myofascial release for 1 months 3 sessions per week
| Study group | Role | What they receive |
|---|---|---|
| diaphragmatic release | Experimental | diaphragmatic myofascial release Receives: Other: diaphragmatic release |
| positioning | Active comparator | positioning instruction for sleep apnea Receives: Other: diaphragmatic release |
What is being measured
The primary outcome is the main question the study is designed to answer.
pittshurgh sleep quality index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh,
Measured: 1 month
Secondary outcomes (1)
diaphragmatic excursion assessment
diaphragmatic excursion assessment is that measures the movement of the thoracic diaphragm during breathing. Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm2.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Nov 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion17 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEEP APNEA PREGNANCYStudies 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
- Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa Mohamed hamed, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273787
- Sponsor's protocol ID
- Mitu
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diaphragmatic Release in Sleep Quality During Pregnancy, Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06273787
- Acronym / sponsor ID
- Mitu
- Conditions
- SLEEP APNEA PREGNANCY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 17 Mar 2024 (estimated)
- First posted
- 23 Feb 2024 (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.
Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy.
Detailed description
The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will provide scientific basis for the clinical application of diaphragmatic release in sleep disordered breathing during pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction
| Arm | Type | Receives |
|---|---|---|
| diaphragmatic release | Experimental | Other: diaphragmatic releasediaphragmatic myofascial release |
| positioning | Active comparator | Other: diaphragmatic releasepositioning instruction for sleep apnea |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women (at third trimester), diagnosed with sleep disordered breathing by the gynaecologist.
- Their ages will range from 30- 40 years old .
- Their BMI will be 25 to 30kg/m2.
- All are multipara.
Key exclusion criteria (6 listed)
- Previous pulmonary surgery.
- any pulmonary diseases.
- Asthma.
- Neurological disorders
- Musculoskeletal disorders (severe osteoarthritis, osteoporosis)
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 releasediaphragmatic myofascial release for 1 months 3 sessions per week | Other | diaphragmatic release, positioning |
Primary outcome
pittshurgh sleep quality index
Time frame: 1 month
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh,
1 secondary outcome
diaphragmatic excursion assessment
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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. This study is not recruiting at the moment.
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 release in people with SLEEP APNEA PREGNANCY, run by MTI University 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 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shaimaa M mohamed, doctoral (01008585299, shaimaa.moamed@pt.mti.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pittshurgh sleep quality index (time frame: 1 month). 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 23 Feb 2024.