An interventional study of Home-based hyperthermic Baths in CDKL5 Deficiency Disorder, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting. Open to participants aged 6 Months to 14 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
The primary objective of this research is to study the efficacy and safety of daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder.
This is a prospective, randomized, open-label, blinded-endpoint study designed to evaluate the efficacy and safety of daily home-based hyperthermic bathing in participants with CDKL5 deficiency disorder. Eligible participants will be randomized in a 1:1 ratio to receive either hyperthermic baths in addition to usual antiseizure care or usual antiseizure care alone without hyperthermic baths. Efficacy will be assessed primarily by changes in epileptic seizure burden, and safety will be evaluated throughout the study period.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 34 is below the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
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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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with CDKL5 deficiency disorder assigned to the daily home-based hyperthermic bathing group will undergo immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision.
Behavioral: Home-based hyperthermic Baths
Participants assigned to the control group will not receive hyperthermic baths during the study period and will continue their usual care, including their existing antiseizure treatment regimen. Seizure frequency and safety outcomes will be assessed according to the study protocol.
A 12-week daily home-based hyperthermic bathing intervention consisting of immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision. The intervention will be administered according to the study protocol.
Seizure Responder Rate
The proportion of participants achieving at least a 50% reduction in seizure frequency from baseline during the 12-week home-based hyperthermic baths period.
Time frame: Baseline to week 12 at home-based hyperthermic baths phase
Change in Seizure Frequency
Change in the frequency of epileptic seizures from baseline to the 12-week home-based hyperthermic baths period.
Time frame: Baseline to week 12 at home-based hyperthermic baths phase
Seizure-free Days
Number of days without epileptic seizures during the 12-week treatment period.
Time frame: Baseline to week 12 at home-based hyperthermic baths phase
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 16 months is close to that.
Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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