Melatonin in Adults With SMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2019-03-30

Brief Summary

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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

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Detailed Description

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SMS is one of the rare syndromes in which the inversion of melatonin secretion is regular, which is an exceptional situation for the study of the influence of genetic factors on the regulation of sleep / wake rhythm. Recently, point mutations of the RAI1 gene (Retinoic Acid Induced 1) have been identified in individuals with the clinical features of SMS with a reversal of the secretion rate of melatonin ,highlighting the role of RAI1 in SMS sleep disorders.

Daytime secretion of melatonin is associated with significant drowsiness and plays a major role in diurnal behavior disorders, especially in younger people. Conversely, the absence of nocturnal melatonin is a causal factor in the shortening and fragmentation of nocturnal sleep .

Basically, little is known about the mechanisms that explain the inversion of the secretion rate of melatonin in SMS.

These aspects, and in particular the nycthemeral reversal of the melatonin cycle, have been described in a population of children and we do not know how these disturbances evolve in adulthood

Conditions

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Smith Magenis Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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10 adult patients with SMS

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

Group Type OTHER

Hourly dosing of the nychtemeral secretion of melatonin

Intervention Type BIOLOGICAL

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

Interventions

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Hourly dosing of the nychtemeral secretion of melatonin

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No