Patient Registry of Blind Subjects With Sleep-related Problems

Vanda Pharmaceuticals

Status: Enrolling

Conditions: Sleep-wake Disorder in Blind Individuals

Treatments: Other: Data collection on blindness and sleep problems

Study type: Observational

Funder types: Industry

Identifiers

NCT01195558

Pro00005099

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

10,000 participants in 1 patient group

Blind with sleep problems

Description:

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

Treatment:

Other: Data collection on blindness and sleep problems