Patient Registry of Totally Blind Subjects With Sleep-related Problems
| Tracking Information | |||||
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| First Received Date ICMJE | September 2, 2010 | ||||
| Last Updated Date | June 25, 2012 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01195558 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Patient Registry of Totally Blind Subjects With Sleep-related Problems | ||||
| Official Title ICMJE | Development of a Patient Registry of Totally Blind Subjects With Sleep-related Problems | ||||
| Brief Summary | Non-24-hour sleep-wake disorder (N24HSWD) 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 N24HSWD and who are totally blind with no light perception. Subjects participate in the study through a phone survey. This patient registry will be used to better understand sleep related problems in blind individuals, and identify subjects who are interested in participating in research and clinical studies related to N24HSWD. The survey consists of questions regarding the degree of vision impairment and sleep problems that the subjects may be experiencing. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | General population of totally blind individuals |
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| Condition ICMJE | Sleep-wake Disorder in Totally Blind Individuals | ||||
| Intervention ICMJE | Other: Data collection on blindness and sleep problems
Data related to degree of vision impairment and sleep problems is collected through a phone survey
Other Name: Data Collection |
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| Study Group/Cohort (s) | Totally blind with sleep problems
Totally blind individuals with no light perception and with sleep-related problems who may suffer from N24HSWD
Intervention: Other: Data collection on blindness and sleep problems |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10000 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01195558 | ||||
| Other Study ID Numbers ICMJE | Pro00005099 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Vanda Pharmaceuticals | ||||
| Study Sponsor ICMJE | Vanda Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Vanda Pharmaceuticals | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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