Safety and Efficacy of Melsoma Nano Spray for Treating Sleep Disturbances in Children with ADHD

Aim:

1)      To study prevalence and type of sleepdisturbances in children with ADHD

2)       Tostudy safety and efficacy of Melsoma Nano Spray in treating sleep disturbancesin children with ADHD

Primary objective:

To determine the changes in the severity ofinsomnia by using Insomnia Severity Index (ISI) scale.

Secondary objective:

To document any adverse events associated with theuse of Melsoma Nano Spray

Study Site:

Out-patient departmentsof Pediatrics and Psychiatry of LTMMC and LTMGH, Sion, Mumbai.

Duration of Study:

Approximately 6 Months.

Study Description:

Design:

Single Centre, Openlabel, Prospective, Interventional, & Active Post-Marketing Surveillancestudy

Sample Size:

Sixty (60) patients willbe recruited in the study

Sample Method:

All patients fulfillinginclusion criteria will be included in the study

StudyPopulation:

·        Inclusion Criteria:

1.      Children who meet DSM-5 criteria forADHD.

2.      ADHD patients with the complaints ofsleep disorder.

3.      Patientswho are not on any sedating drugs and having complaints of sleep disturbances.

4.      Willingness and able to give informedconsent, and comply with requirements for participation in the study.

Exclusion criteria:

1.    Childrenwith other psychiatry and medical illness will not be included.