Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01195558 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Patient Registry of Blind Subjects With Sleep-related Problems

StatusRecruiting
PhaseNot specified
Started2010-04
View on ClinicalTrials.gov ↗

Amendment history

2020-06-22
Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 1 site
2017-12-12
Study Status, Contacts/Locations v11
Completion datenot stated→2030-04
2016-06-10
3 amendments v8-v10
3 re-verifications since 2015-01-05, no change to tracked fields
2014-06-18
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Eligibility criteria+213 characters
Inclusion Criteria: TotallySubjects 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. Subjects must be blind. Subjects must have some self-described problem with history of sleep disturbances Exclusionor Criteria: Perceivedaytime light from either eyesleepiness.
Primary endpoints1 entry, revised
Number of totally blind participants
Study sitescontacts updated at 1 of 1 site
Study title-8 characters
Patient Registry of Totally Blind Subjects With Sleep-related Problems
2014-02-03
Study Status v6
Re-verified, no change to tracked fields
Show 5 earlier versions
2013-06-05
Study Status, Outcome Measures, Contacts/Locations v5
Primary completion datenot stated→2030-04
Study sitesdetails revised at 1 of 1 site
2012-06-25
2 amendments v3-v4
2 re-verifications since 2011-06-08, no change to tracked fields
2010-11-19
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2010-11-17
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields
2010-09-03
Original filing
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.
Trial Details
NCT Number NCT01195558
Lead Sponsor Vanda Pharmaceuticals
Conditions Sleep-wake Disorder in Blind Individuals
Enrollment 10,000 participants
Start Date 2010-04
Primary Completion 2030-04 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2020-06-24