Melatonin in Adults With SMS

NCT03492970 | Completed

• 1 other identifier: 2017-A02299-44
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an inversion of the nychtemeral secretion of melatonin. This inversion have been described in children with SMS. However its evolution during adulthood remains unknown. The aim of this study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize medication in adults with SMS

Conditions

Smith Magenis Syndrome

Outcome Measures

Primary Outcomes (1)

• 24h melatonin levels

  Plasmatic melatonin level will be assessed every hour during 24h for each subject

  24 hours

Secondary Outcomes (1)

• Analysis of actimetry

  15 days

Study Arms (1)

10 adult patients with SMS

OTHER

Specify the evolution of the nycthemeral cycle of melatonin secretion in adult subjects carrying an SMS Behavioral characterization of adult subjects with SMS Make recommendations on the management of sleep / sleep rhythm disorders and behavior in adult subjects with SMS

Biological: Hourly dosing of the nychtemeral secretion of melatonin

Interventions

Hourly dosing of the nychtemeral secretion of melatonin BIOLOGICAL

Hourly dosing of the nychtemeral secretion of melatonin links and with sleep disorders and behavior of adult patients with SMS

10 adult patients with SMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with Smith Magenis Syndrome aged 18 years or older
• subject or guardian having signed the consent

You may not qualify if:

• Pregnant women
• Minor subject
• Diagnosis of Smith Magenis syndrome not certain
• Taking benzodiazepines or related substances
• Taking betablockers
• Major behavioral disorders versus indicating participation in this study

Sponsors & Collaborators

• Hôpital le Vinatier: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

CH Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Smith-Magenis Syndrome

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• POISSON ALICE, PH

  CH LE VINATIER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To specify the evolution of the nycthéméral cycle of the secretion of melatonin in 10 adult subjects carrying a SMS

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: April 10, 2018
• Study Start: March 7, 2018
• Primary Completion: January 30, 2019
• Study Completion: March 30, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)