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Patient Registry of Blind Subjects With Sleep-related Problems

This study is currently recruiting participants.
Verified December 2017 by Vanda Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195558
First Posted: September 6, 2010
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanda Pharmaceuticals
September 2, 2010
September 6, 2010
December 14, 2017
April 2010
April 2030   (Final data collection date for primary outcome measure)
Number of blind participants [ Time Frame: ongoing ]
Not Provided
Complete list of historical versions of study NCT01195558 on ClinicalTrials.gov Archive Site
Sleep/wake disruptions [ Time Frame: ongoing ]
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
April 2030
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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Vanda Pharmaceuticals 1-844-361-2424
United States
 
 
NCT01195558
Pro00005099
No
Not Provided
Not Provided
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Not Provided
Principal Investigator: Joseph T. Hull, PhD Vanda Pharmaceuticals
Vanda Pharmaceuticals
December 2017