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
  Purpose

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.


Condition Intervention
Sleep-wake Disorder in Totally Blind Individuals
Other: Data collection on blindness and sleep problems

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of a Patient Registry of Totally Blind Subjects With Sleep-related Problems

Resource links provided by NLM:


Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • Number of totally blind participants [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep/wake disruptions [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: April 2010
Estimated Primary Completion Date: April 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Totally blind with sleep problems
Totally blind individuals with no light perception and with sleep-related problems who may suffer from N24HSWD
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

General population of totally blind individuals

Criteria

Inclusion Criteria:

  • Totally blind with history of sleep disturbances

Exclusion Criteria:

  • Perceive light from either eye
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195558

Contacts
Contact: Vanda Pharmaceuticals 1-877-708-1936

Locations
United States, District of Columbia
Vanda Pharmaceuticals Recruiting
Washington, District of Columbia, United States, 20037
Contact    877-708-1936      
Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
Principal Investigator: Christian Lavedan, Ph.D. Vanda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01195558     History of Changes
Other Study ID Numbers: Pro00005099
Study First Received: September 2, 2010
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanda Pharmaceuticals:
N24HSWD
Blindness
Sleep
Wake
Circadian Rhythm
Nap

ClinicalTrials.gov processed this record on April 17, 2014