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New moms' insomnia tackled with sleep coaching and exercise

NCT ID NCT07345065

Symptom relief Sponsor: De deyne Manon Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether person-centered behavioral programs can improve sleep in first-time mothers with insomnia. 135 women will either receive a sleep management program, an aerobic exercise program, or usual care. The main goal is to see if these approaches reduce insomnia severity and improve quality of life.

What this could mean

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

Active substance
Behavioural Sleep Management program and Behavioural Aerobic Exercise program
What this could lead to
If successful, this could provide simple, non-drug options to help new mothers sleep better and improve their daily functioning.
What could go wrong
This is a small, early-stage trial with only 135 participants, so results may not apply to all mothers. The interventions require commitment and may not work for everyone.

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 135 people

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

Started

Jan 2026

Expected to finish

Nov 2028

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 years and older

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: Women are eligible for study participation if they: * (1) Have had a singleton pregnancy. * (2) Are between 4 to 12 months postpartum with their first child. * (3) Exhibit (sub)clinical insomnia, operationalized as an Insomnia Severity Index (ISI) score greater than 7 7 and having answered 'yes' on the following three statements: a) I have trouble falling asleep, and/or staying asleep and/or I have early morning awakenings AND this causes daytime symptoms. b) My sleeping problem is not caused by an external factor (the baby or my partner). c) These sleeping problems occur at least 3 times a week for at least 3 months. * (4) Have access to a telephone, computer, and email. * (5) Possess adequate Dutch literacy to comprehend therapy content, questionnaires, and instructions. Exclusion Criteria: Women are excluded from participation if they: * (1) Are currently pregnant. * (2) Are shift workers. * (3) Have severe diagnosed psychopathologies (e.g., bipolar disorder, post-traumatic stress disorder, psychosis) * (4) Have current severe or untreated sleep disorders (narcolepsy, restless legs syndrome, circadian rhythm disorders) * (5) Have an unstable medical condition that may disrupt sleep. * (6) Have received cognitive-behavioural therapy for insomnia (CBTi) within the last 6 months. * (7) Experience sleep deprivation due to unsettled infant sleep/wake behaviour, defined as the infant waking more than three times per night for more than 30 minutes and requiring parental support to re-initiate sleep.

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Conditions

The condition(s) this trial relates to.

insomnia Motor Activity

As listed by the trial registrant

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

Insomnia

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • KU Leuven, Departement of Physiotherapy

    RECRUITING

    Leuven, Leuven, 3000, Belgium

  • Vrije Universiteit Brussel, Health Campus, Department of Physiotherapy

    RECRUITING

    Brussels, Jette, 1090, Belgium

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