Recruiting

Observational Study

Sponsor:

Vanda Pharmaceuticals

Code:

NCT01195558

Conditions

Sleep-wake Disorder in Blind Individuals

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Data collection on blindness and sleep problems

Study Details

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.

Conditions

Sleep-wake Disorder in Blind Individuals

Study ID

NCT01195558

Start date

Apr, 2010

Status verified date

Jun, 2020

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Blind with sleep problems

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

Interventions

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

Primary outcome measure

  • Number of blind participants [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals

(202) 734-3400

Locations

Vanda Pharmaceuticals

Recruiting

Washington, District of Columbia, United States, 20037

Contacts

Vanda Pharmaceuticals

202-734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Jun 24, 2020

Last verified

Jun, 2020

Keywords

  • Non-24
  • N24HSWD
  • Blindness
  • Sleep
  • Wake
  • Circadian Rhythm
  • Nap

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2020-06-24.