Sleep-wake Disorder in Blind IndividualsNCT01195558
Patient Registry of Blind Subjects With Sleep-related Problems
An observational study of Sleep-wake Disorder in Blind Individuals, run by Vanda Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep-wake Disorder in Blind Individuals
- What is being tested?
- Data collection on blindness and sleep problems
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General population of blind individuals
Who may be able to join
- 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.
- Subjects must be blind.
- Subjects must have some self-described problem with sleep or daytime sleepiness.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vanda Pharmaceuticals contact
United States1 site, 1 recruiting
- Recruiting
Vanda Pharmaceuticals
Washington D.C., District of Columbia, 20037
Vanda Pharmaceuticals, 202-734-3400
About this study
Official title: Development of a Patient Registry of Blind Subjects With Sleep-related Problems
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
- Being tested
- Data collection on blindness and sleep problems
- Keywords
- Non-24, N24HSWD, Blindness, Sleep, Wake, Circadian Rhythm, Nap
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on blindness and sleep problemsOther
Also called Data Collection
Data related to degree of vision impairment and sleep problems is collected through a phone or web survey
| Study group | Role | What they receive |
|---|---|---|
| Blind with sleep problems | Blind individuals with no light perception and with sleep-related problems who may suffer from Non-24 Receives: Other: Data collection on blindness and sleep problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blind participants
Measured: ongoing
Secondary outcomes (1)
Sleep/wake disruptions
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-wake Disorder in Blind IndividualsStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195558
- Sponsor's protocol ID
- Pro00005099
- Status last verified
- Jun 2020
- First submitted
- 2 Sep 2010
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient Registry of Blind Subjects With Sleep-related Problems
- ClinicalTrials.gov ID
- NCT01195558
- Acronym / sponsor ID
- Pro00005099
- Conditions
- Sleep-wake Disorder in Blind Individuals
- Keywords
- Non-24, N24HSWD, Blindness, Sleep, Wake, Circadian Rhythm, Nap
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blind with sleep problems | – | Other: Data collection on blindness and sleep problemsBlind individuals with no light perception and with sleep-related problems who may suffer from Non-24 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population of blind individuals
Key inclusion criteria (3 listed)
- 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.
- Subjects must be blind.
- Subjects must have some self-described problem with sleep or daytime sleepiness.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection on blindness and sleep problemsAlso: Data CollectionData related to degree of vision impairment and sleep problems is collected through a phone or web survey | Other | Blind with sleep problems |
Primary outcome
Number of blind participants
Time frame: ongoing
1 secondary outcome
Sleep/wake disruptions
Time frame: ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanda Pharmaceuticals contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-wake Disorder in Blind Individuals, run by Vanda Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals ((202) 734-3400), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blind participants (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.