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RecruitingNCT06273787Updated Feb 23, 2024

Effect of Diaphragmatic Release in Sleep Quality During Pregnancy

An interventional study of diaphragmatic release in SLEEP APNEA PREGNANCY, sponsored by MTI University. Recruiting at 1 site in Egypt. Open to female participants aged 30 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by MTI University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Nov 2023, registered Feb 2024).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
30 Years to 40 Years
Sex
Female
01

Study 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.

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

02

Conditions studied

  • SLEEP APNEA PREGNANCY
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's planned enrollment of 44 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

MTI University is the lead sponsor of 58 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

Women will be excluded from the study if they have:

  • Previous pulmonary surgery.
  • any pulmonary diseases.
  • Asthma.
  • Neurological disorders
  • Musculoskeletal disorders (severe osteoarthritis, osteoporosis)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    diaphragmatic release

    diaphragmatic myofascial release

    Other: diaphragmatic release

  • Active comparator
    positioning

    positioning instruction for sleep apnea

    Other: diaphragmatic release

Interventions

  • Otherdiaphragmatic release

    diaphragmatic myofascial release for 1 months 3 sessions per week

06

What researchers measure

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,

    Time frame: 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.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • MTI
    Cairo, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06273787
Lead sponsor
MTI University
Responsible party
shaimaa Mohamed hamed (Lecturer of physical therapy for women's health in MTIU, MTI University) — Principal investigator
First posted
Feb 23, 2024
Start date
Nov 1, 2023
Primary completion
Feb 29, 2024 (estimated)
Completion
Mar 17, 2024 (estimated)
Last update
Feb 23, 2024

Study contacts

shaimaa M mohamed, doctoral
Contact
shaimaa.moamed@pt.mti.edu.eg
01008585299

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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