Patient Registry of Totally Blind Subjects With Sleep-related Problems

This study is currently recruiting participants.
Verified February 2014 by Vanda Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01195558
First received: September 2, 2010
Last updated: February 3, 2014
Last verified: February 2014

September 2, 2010
February 3, 2014
April 2010
April 2030   (final data collection date for primary outcome measure)
Number of totally blind participants [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Not Provided
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 Totally Blind Subjects With Sleep-related Problems
Development of a Patient Registry of Totally Blind Subjects With Sleep-related Problems

Non-24-hour sleep-wake disorder (N24HSWD) 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 N24HSWD and who are totally blind with no light perception. Subjects participate in the study through a phone survey. This patient registry will be used to better understand sleep related problems in blind individuals, and identify subjects who are interested in participating in research and clinical studies related to N24HSWD. 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
Not Provided
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Probability Sample

General population of totally blind individuals

Sleep-wake Disorder in Totally 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 survey
Other Name: Data Collection
Totally blind with sleep problems
Totally blind individuals with no light perception and with sleep-related problems who may suffer from N24HSWD
Intervention: Other: Data collection on blindness and sleep problems
Not Provided

*   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:

  • Totally blind with history of sleep disturbances

Exclusion Criteria:

  • Perceive light from either eye
Both
18 Years and older
Yes
Contact: Vanda Pharmaceuticals 1-877-708-1936
United States
 
NCT01195558
Pro00005099
No
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Not Provided
Principal Investigator: Christian Lavedan, Ph.D. Vanda Pharmaceuticals
Vanda Pharmaceuticals
February 2014

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