Patient Registry of Blind Subjects With Sleep-related Problems

Recruiting

• Conditions: Sleep-wake Disorder in Blind Individuals
• Interventions: Other: Data collection on blindness and sleep problems

• Registration Number: NCT01195558
• Lead Sponsor: Vanda Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-24
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blind with sleep problems	Data collection on blindness and sleep problems	Blind individuals with no light perception and with sleep-related problems who may suffer from Non-24

Primary Outcome Measures

Name	Time	Method
Number of blind participants	ongoing

Secondary Outcome Measures

Name	Time	Method
Sleep/wake disruptions	ongoing

Trial Locations

Locations (1)

Vanda Pharmaceuticals; 🇺🇸 Washington, District of Columbia, United States