Patient Registry of Blind Subjects With Sleep-related Problems

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vanda Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01195558
First received: September 2, 2010
Last updated: June 18, 2014
Last verified: June 2014

September 2, 2010
June 18, 2014
April 2010
April 2030   (final data collection date for primary outcome measure)
Number of blind participants [ Time Frame: ongoing ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01195558 on ClinicalTrials.gov Archive Site
Sleep/wake disruptions [ Time Frame: ongoing ] [ Designated as safety issue: No ]
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Patient Registry of Blind Subjects With Sleep-related Problems
Development of a Patient Registry of Blind Subjects With Sleep-related Problems

Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. This is a research protocol to develop a patient registry of subjects who may suffer from Non-24 and who are blind. Subjects participate in the study through a phone survey. This registry will be used to better understand, sleep related problems in blind individuals, including the investigation of a potential treatment, recruitment for future clinical studies, and to provide a forum for raising awareness about Non-24. The survey consists of questions regarding the degree of vision impairment and sleep problems that the subjects may be experiencing.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample

General population of blind individuals

Sleep-wake Disorder in Blind Individuals
Other: Data collection on blindness and sleep problems
Data related to degree of vision impairment and sleep problems is collected through a phone or web survey
Other Name: Data Collection
Blind with sleep problems
Blind individuals with no light perception and with sleep-related problems who may suffer from Non-24
Intervention: Other: Data collection on blindness and sleep problems
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
Not Provided
April 2030   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects or legal guardians must be at least 18 years of age to participate in the telephone survey. Parents or legal guardians may represent children from 0 through 17 years who meet the following criteria.
  2. Subjects must be blind.
  3. Subjects must have some self-described problem with sleep or daytime sleepiness.
Both
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No
Contact: Vanda Pharmaceuticals 1-844-361-2424
United States
 
NCT01195558
Pro00005099
No
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Not Provided
Principal Investigator: Seth Smith, Pharm.D., MBA Vanda Pharmaceuticals
Vanda Pharmaceuticals
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP