Sleep Abnormalities in Rare Genetic Disorders: AS, RTT, and PW

Completed

Conditions studied: Rett Syndrome, Prader-Willi Syndrome, Angelman Syndrome, Sleep Problems

In brief

This study will investigate sleep behavior in subjects with Angelman Syndrome, Rett Syndrome or Prader-Willi Syndrome. The study will also investigate sleep behavior in healthy siblings of subjects with Angelman Syndrome, Rett Syndrome or Prader-Willi Syndrome. These individuals will serve as control subjects. The study will use questionnaires designed to identify sleep disorders and how they affect behavior and quality of life. The principal goals of this study are: 1. To see how common sleep disorders are in individuals with Angelman Syndrome, Rett Syndrome or Prader-Willi Syndrome; 2. To see how sleep disorders affect behavior in these individuals; 3. To see whether sleep disorders and related behavior problems improve or worsen with age; 4. To see how specific disease conditions relate to sleep disorders and how bad the sleep disorders are; 5. To develop new treatment options to improve quality of life and behavior issues; and 6. To evaluate current treatment options to improve sleep problems in these individuals.

Key facts

Study ID

NCT02670694

Run by

Baylor College of Medicine

People needed

804

Starts

2011-06-01

Expected to finish

2013-07-01

Last updated by the study team

2016-02-02

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligible Inclusion Criteria - Subjects
• Enrollment in a RDCRN consortium registry for either AS, RTT or PWS.
• Have a clinical diagnosis of AS, RTT or PWS, or be a normal sibling of an individual with AS, RTT or PWS who is enrolled in the study.
• Be between 0 to18 years of age inclusive.
• Be English-speaking (study questionnaires will only be available in English).
• Inclusion Criteria - Controls
• Must have a sibling with either AS, RTT or PWS enrolled in the study.
• Must not have a diagnosis of any neurological disorder.
• Be between 0 to18 years of age inclusive
• Be English-speaking (study questionnaires will only be available in English).

You may not qualify if…

• Exclusion Criteria - Subjects
• No clinical diagnosis of AS, RTT, or PWS.
• Diagnosis of a severe genetic disorder in addition to AS, RTT, or PWS.
• Be over 18 years of age inclusive.
• Exclusion Criteria - Controls
• Diagnosis of a neurological disorder.
• Diagnosis of a severe genetic disorder.
• Be over 19 years of age inclusive.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, Irvine Medical Center — Irvine, California, United States
• Rady Children's Hospital — San Diego, California, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Greenwood Genetic Center — Greenwood, South Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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