The effect of melatonin on sleep disorders in children with cerebral palsy

The study of effectiveness of melatonin on sleep disorders in children with cerebral palsy (CP)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191017045142N1

Enrollment

Registered

2021-07-07

Start date

2018-07-23

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: cerebral palsy. Condition 2: Sleep disorders. Spastic quadriplegic cerebral palsy Sleep disorders

Interventions

Intervention 1: Intervention group: Patients receive 3 mg oral melatonin tablets produced by (Razak company) 30 minutes before going to sleep. Next, the patient wears a smart watch which, based on the

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children with cerebral palsy with sleep disorders

Exclusion criteria

Exclusion criteria: Change in medication which can affect sleep in the past month such as anticonvulsants and sedatives

Design outcomes

Primary

Measure	Time frame
Time required to start sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medicationwith the first two nights (without medication). Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.;Duration of sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.;Duration of deep sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.;Duration of light sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.	—

Measure

Time frame

Time required to start sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medicationwith the first two nights (without medication). Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.;Duration of sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.;Duration of deep sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.;Duration of light sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Reza Goldouzi

Mashhad University of Medical Sciences

hamid.reza.goldozian@gmail.com+98 51 3846 2224

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026