Health TrialsbyHealthPanel

Impact of Bright Light Therapy on Prader-Willi Syndrome

ConditionsPrader-Willi SyndromeExcessive Daytime SleepinessHyperphagiaBody WeightMoodBehavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-88
SponsorMaimonides Medical Center

About this trial

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of PWS confirmed by genetic testing

Score of 12 or above on the Epworth Sleepiness Scale (ESS).

Disqualifiers

Subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications

A history of previous treatment with LT

Patients presenting with active psychosis or mania

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sham Light

    Other intervention

    Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.

  • Bright Light Therapy

    Other intervention

    Bright Light Therapy will be provided using light box with an artificial full spectrum lamp at a distance of at least 70cm but no greater than 90cm.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Sham LightSham comparator 1 intervention
Group B: Light TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Global Impression- Improvement (CGI-I)

A positive clinical response will be determined by a rating of 1 or 2 (Very much/Much improved) on the Clinical Global Impression- Improvement (CGI-I) scale at the end of the blinded trial.

Time frame
8 Weeks

Secondary outcomes

1

Aberrant Behavior Checklist

Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).

Time frame
8 Weeks
2

Self-Injury Trauma scale

Scores of 5 or greater were found to be indicative of borderline personality disorder. Part 1 is ranking based on the number of wounds 1=one would (common in a mild self-injurious behavior but rare in a severe case) 2=two or four wounds (common) and 3=five or more wounds (rare). Injury severity is scored on a subjective basis with labels such as "mild" "moderate" and "severe" accompanied by descriptions of the observed state of the anatomy. Part 3 is the Estimate of Current Risk.

Time frame
8 Weeks
3

Modified Overt Aggression Scale

Four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes.\[1\] The rating scale is made up of four categories; verbal aggression, aggression against objects, aggression against self, and aggression against others

Time frame
8 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maimonides Medical Center

Lead sponsor

Foundation for Prader-Willi Research

Collaborator

Source ClinicalTrials.gov
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