Melatonin Levels in Smith Magenis Syndrome (SMS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00691574
• Date of registration: 30/05/2008
• Prospective Registration: No
• Primary sponsor: Oregon Health and Science University
• Public title: Melatonin Levels in Smith Magenis Syndrome (SMS)
• Scientific title: Melatonin Levels in Sleep-disordered Smith-Magenis Syndrome: a Pilot Study
• Date of first enrolment: September 1998
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00691574
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Eilis Boudreau, MD
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Control participants:

- 30 individuals: ages 55-85,

- healthy without significant active medical problems.

- SMS patients:

- 20 individuals: ages 3-50,

- with a clinical diagnosis of Smith-Magenis Syndrome by a qualified Medical
Geneticist, confirmed by cytogenetic analysis documenting deletion of chromosome
band 17p11.2.

Exclusion Criteria:

- Control participants:

- A current Axis I psychiatric or substance abuse disorder according to the DSM-IV
Manual, abnormal heart, liver or kidney function, diagnoses of neurodegenerative
or cerebrovascular disease (Alzheimer's disease, Parkinson's disease, stroke,
etc.),

- cognitive impairment (Mini-Mental State Score < 23) but without a formal
diagnosis of dementia,

- active symptoms of depression (Geriatric Depression Scale: 30 pt. version > 10),

- current diagnosis of cataracts,

- macular degeneration or retinopathy based on eye exam by an optometrist or
ophthalmologist within the past year.



Age minimum: 3 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chromosome Disorders

Intervention(s)

Device: Enviro-light artificial light box

Dietary Supplement: Melatonin

Primary Outcome(s)

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples [Time Frame: every 2-4 weeks throughout the entire study]

Secondary Outcome(s)

Wrist Actigraph Activity Levels as a Secondary Indicator of Circadian Phase [Time Frame: every 2-4 weeks throughout the entire study along with every Circadian Phase Marker assessment]

Polysomnography Sleep Disorder Assessment [Time Frame: 1 optional, 12-hour assessment towards the end of the study]

Secondary ID(s)

eIRB 0668

n/a unfunded

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00691574