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A Drug-Free sleep fix for obese pregnant women? trial puts it to the test

NCT ID NCT06890910

Symptom relief Sponsor: Cairo University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a nurse-led program of sleep hygiene education and progressive muscle relaxation can improve sleep quality in obese pregnant women. Researchers will enroll 100 women in their third trimester with a BMI of 30 or higher and sleep problems. Half will receive the intervention, which includes advice on sleep habits, bedroom environment, and relaxation exercises practiced twice daily for four weeks. The other half will receive routine prenatal care. The study measures changes in sleep quality and sleep hygiene using standard questionnaires.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A nurse-led program combining sleep hygiene education and progressive muscle relaxation training
What this could lead to
If it works, this could give doctors a simple, drug-free way to improve sleep and reduce pregnancy complications in obese women.
What could go wrong
This is a small, early-stage trial with 100 participants, so results may not apply to all pregnant women. The intervention depends on women practicing relaxation daily, and adherence may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Apr 2024

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * primigravida or multigravida women with any type of sleep disorder during pregnancy either insomnia, obstructive sleep apnea, restless leg syndrome, parasomnias; age 18-40 years old; obese women with body mass index (BMI) ≥ 30; being in the third trimester of pregnancy(28-34weeks of gestation) Exclusion Criteria: * having known risk of current pregnancy (preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios, twin pregnancy, etc.); having known problem about fetus health (IUGR, anomaly, etc.); diagnosed with a sleep disorder for a different reasons and received treatment for it; history of psychiatric or somatic disorders; recent administration of psychoactive, sedative, or narcotic medications, and use of caffeine ( more than 8cups of coffee or 16 cups of tea/day).

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Conditions

The condition(s) this trial relates to.

Obesity sleep disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obese pregnant women Sleep disorders

Contacts and locations

Locations

  • Faculty of nursing at Cairo university

    Cairo, Kase AlAini/El-Manial, 11562, Egypt

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