Effect of Diaphragmatic Release in Sleep Quality During Pregnancy

NCT06273787 | Recruiting

• 1 other identifier: Mitu
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy.

Conditions

SLEEP APNEA PREGNANCY

Outcome Measures

Primary Outcomes (1)

• 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,

  1 month

Secondary Outcomes (1)

• diaphragmatic excursion assessment

  1 month

Study Arms (2)

diaphragmatic release

EXPERIMENTAL

diaphragmatic myofascial release

Other: diaphragmatic release

positioning

ACTIVE COMPARATOR

positioning instruction for sleep apnea

Other: diaphragmatic release

Interventions

diaphragmatic release OTHER

diaphragmatic myofascial release for 1 months 3 sessions per week

diaphragmatic release; positioning

Eligibility Criteria

• Age: 30 Years - 40 Years
• Gender Eligibility Details: pregnant female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women will be excluded from the study if they have:
• Previous pulmonary surgery.
• any pulmonary diseases.
• Asthma.
• Neurological disorders
• Musculoskeletal disorders (severe osteoarthritis, osteoporosis)

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

MTI

Cairo, Egypt

RECRUITING

Central Study Contacts

shaimaa M mohamed, doctoral

CONTACT

01008585299; shaimaa.moamed@pt.mti.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for women's health in MTIU

Model Details: Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: November 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: March 17, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

EG (1)