Improving Sleep of Children With Neurodevelopmental Disorders: Pulsed Current Stimulation Versus Melatonin

NCT06236191 | Unknown

• 1 other identifier: 2022/2216
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomised controlled trial that evaluates whether transcranial pulsed current stimulation increased total sleep time in children with neuroevelopmental disorder, compared to Melatonin

Conditions

Insomnia; Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

• Total sleep time (TST)

  Improvement in TST; the higher the TST the better

  4 weeks

Secondary Outcomes (4)

• Sleep latency (SL)

  4 weeks

• Sleep efficiency (SE)

  4 weeks

• wake after sleep onset (WASO)

  4 weeks

• Total score in sleep questionnaire

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group is transcranial pulse electrical stimulation

Device: transcranial pulsed current stimulation

Comparator

ACTIVE COMPARATOR

comparator is Melatonin

Drug: Melatonin

Interventions

transcranial pulsed current stimulation DEVICE

A form of transcranial electrical stimulation that delivers unidirectional monophasic rectangular pulses of current.

Intervention

Melatonin DRUG

Melatonin

Comparator

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 4-16
• Neurodevelopmental disorder including cerebral palsy, autistic spectrum disorder, neurogenetic syndrome.
• Patients whose pre-intervention sleep questionnaire total score more than 46 and/or pre-intervention sleep questionnaire T-score more than 70 in any sleep domain
• Children agree to tPCS as per procedure and consent to the study, including need to shave hair at the site of stimulation at the occiput
• Parents/carers agree to tPCS as per visit schedule and procedure
• Medical practitioner's approval

You may not qualify if:

• History of uncontrolled epileptic disorders and seizures, brain tumours or trauma and mental diseases, substance abuse or dependence, use of benzodiazepines, neuroleptic, serotonin or dopaminergic drugs, presence of metal/ electronic implant in brain/ body eg. shunt, cochlear implant, pacemaker or defibrillator, untreated known obstructive sleep apnoea or another previously diagnosed sleep disorder, and current involvement in other tDCS or rTMS trials. Patients with history of drug allergy to Melatonin will also be excluded.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KKWCH

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neurodevelopmental Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Zhi Min Ng

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Min Ng, MBBS, MRCPCH

CONTACT

+65-6394 8975; ng.zhi.min@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor assessing sleep data will be blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover trial using Balaam's design

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: February 1, 2024
• Study Start: July 24, 2023
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)