Patient Registry of Blind Subjects With Sleep-related Problems

Sleep-wake Disorder in Blind Individuals Clinical Trial

Official title:

Development of a Patient Registry of Blind Subjects With Sleep-related Problems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01195558
• Other study ID #: Pro00005099
• Status: Recruiting
• Start date: April 2010
• Est. completion date: April 2030

Study information

• Verified date: June 2020
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmaceuticals
• Phone: (202) 734-3400
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Wake Disorders
• Sleep-wake Disorder in Blind Individuals

Intervention

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

Locations

Country	Name	City	State
United States	Vanda Pharmaceuticals	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of blind participants		ongoing
Secondary	Sleep/wake disruptions		ongoing