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Patient Registry of Blind Subjects With Sleep-related Problems

This study is currently recruiting participants.
Verified June 2016 by Vanda Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195558
First Posted: September 6, 2010
Last Update Posted: June 13, 2016
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
  Purpose
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.

Condition Intervention
Sleep-wake Disorder in 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 Blind Subjects With Sleep-related Problems

Resource links provided by NLM:


Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • Number of blind participants [ Time Frame: ongoing ]

Secondary Outcome Measures:
  • Sleep/wake disruptions [ Time Frame: ongoing ]

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
Blind with sleep problems
Blind individuals with no light perception and with sleep-related problems who may suffer from Non-24
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
General population of blind individuals
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195558


Contacts
Contact: Vanda Pharmaceuticals 1-844-361-2424

Locations
United States, District of Columbia
Vanda Pharmaceuticals Recruiting
Washington, District of Columbia, United States, 20037
Contact    844-361-2424      
Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
Principal Investigator: Seth Smith, Pharm.D., MBA Vanda Pharmaceuticals
  More Information

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01195558     History of Changes
Other Study ID Numbers: Pro00005099
First Submitted: September 2, 2010
First Posted: September 6, 2010
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Vanda Pharmaceuticals:
Non-24
N24HSWD
Blindness
Sleep
Wake
Circadian Rhythm
Nap

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders