Can a few coaching calls help pregnant women sleep better?

NCT ID NCT05530863

Symptom relief Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a simplified behavioral relaxation program can improve sleep in pregnant women with insomnia. Twenty women in their second or third trimester will receive coaching calls and sleep hygiene tips. The goal is to see if this approach helps them fall asleep faster and wake less at night.

What this could mean

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

Active substance: behavioral relaxation intervention (coaching calls and sleep hygiene instructions)
What this could lead to: If it works, this could offer a simple, drug-free way to help pregnant women sleep better.
What could go wrong: This is a very small early study with only 20 participants, so results may not apply to everyone. The intervention may not improve sleep more than standard advice.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

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 55 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: * Age between 18 and 55 * In second or third trimester of pregnancy (Gestation weeks 18-32) * Able to speak, read and write fluent English * Has regular access to a smartphone and/or smart tablet * sleep onset latency (SOL) or nocturnal awakening need be 30 min or more for ≥3 nights/week, must persist for at least 1 month Exclusion Criteria: * Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period. * Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)

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Conditions

The condition(s) this trial relates to.

insomnia pregnancy disorder sleep disorder, initiating and maintaining sleep

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a few coaching calls help pregnant women sleep better?

What the study statuses mean