Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A PROBE Clinical Trial
NCT07602205 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-05-22
Summary
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.
Conditions
- CDKL5 Deficiency Disorder
Interventions
- BEHAVIORAL
-
Home-based hyperthermic Baths
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.
Sponsors & Collaborators
-
Xuanwu Hospital, Beijing
lead OTHER
Principal Investigators
-
Liankun Ren, MD, PhD · Xuanwu Hospital, Beijing
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
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