Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Hot baths tested as seizure treatment for rare childhood disorder

NCT ID NCT07602205

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 taking a daily hot bath (40-42°C for 20 minutes) at home can reduce epileptic seizures in children with CDKL5 deficiency disorder. The trial will include 34 children aged 6 months to 14 years whose seizures are not controlled by medication. Researchers will measure how many participants have at least a 50% drop in seizure frequency over 12 weeks.

What this could mean

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

Active substance
hot water baths (40-42°C for 20 minutes daily)
What this could lead to
If it works, this could offer a simple, drug-free way to reduce seizures in children with CDKL5 deficiency disorder.
What could go wrong
This is a very small early trial with only 34 participants. The treatment is unproven, and hot baths may not reduce seizures or could cause discomfort or safety risks.

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 34 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

6 months to 14 years

Sex

Anyone

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: 1. A diagnosis of CDKL5 deficiency disorder, including molecular confirmation of a pathogenic CDKL5 variant and exhibiting epileptic seizures. 2. Male or female participants aged 6 months to 14 years, inclusive. 3. Patients presenting with drug-resistant epilepsy that seizures were uncontrolled despite the appropriate trial of at least two antiseizure medications (ASMs). 4. At least 8 motor seizures during each 4 weeks in the 8-week historical seizure records preceding screening. 5. Treatment regimens of 0-4 ASMs were required to be stable for at least 4 weeks before screening and throughout the intervention. Ongoing ketogenic diets were allowed if remain unchanged during screening and treatment. 6. Subjects who have undergone surgical implantation of vagus nerve stimulation (VNS) will be eligible for inclusion in the study, provided they meet all of the following criteria: 1. The VNS device has been in place for at least one year prior to the screening visit; 2. The stimulation parameters remain unchanged throughout the duration of the trial. 7. Parents or caregivers must be able and willing to maintain an accurate and comprehensive daily electronic seizure diary throughout the duration of the study. 8. Participants' legal guardians willing to provide written informed consent. Exclusion Criteria: 1. Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes. 2. Participants with skin ulceration or dermatologic conditions that make bathing unsuitable. 3. Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths. 4. A history of seizures induced by thermal baths, or an increase in seizure frequency after thermal baths. 5. Patients who presented any clinical condition that in the opinion of the principal investigator made the patient not suitable to participate in the survey.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for CDKL5 deficiency disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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.

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.