SleepNCT03590795
VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
An observational study of Sleep, run by Philips Respironics at 6 sites in United States.
Trial summary
Sleep is an important contributing factor to people's health. However, over one third of the general population has sleep complaints, causing both health related problems, and economic impact. Many do not think their problem sleep is serious enough to consult a physician (primary care or sleep specialist). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep survey
- How many people
- 204 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Jun 2018to 7 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be those who are new patients to the sleep lab or those recruited from a central recruiter that may or may not have sleep issues.
Who may be able to join
- Age: 20-75 years old.
- Able to provide written informed consent
- Able to read, write and speak English
Who cannot join
- Has seen a sleep physician previously for formal clinical evaluation of a potential sleep problem.
- Is being treated for any sleep disorder.
- Has a major psychiatric disorder that is unstable at the time of evaluation.
- Has a major medical condition likely to contribute to and thus to confound any sleep problem (congestive heart failure, severe Chronic Obstructive Pulmonary Disease (COPD), a pain syndrome, etc).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NeuroTrials Research Inc.
Atlanta, Georgia, 30342
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971
Sleep Therapy and Research Center
San Antonio, Texas, 78229
Clayton Sleep Institute
St Louis, Missouri, 63143
About this study
Sleep is an important contributing factor to people's health. However, over one third of the general population has sleep complaints, causing both health related problems, and economic impact. Many do not think their problem sleep is serious enough to consult a physician (primary care or sleep specialist). For a selection of this population, self-tracking devices can be a solution, but these trackers are often activity based and therefore lacking in their capacity to give insight into underlying causes of poor quality sleep and daytime fatigue.
A new options for these confused sleeper is an online questionnaire, developed by Philips and Cooperative Research Center (CRC) for Alertness, Safety and Productivity Imagine a troubled sleeper awake at 3 am, they search "Why can't I sleep?" and find the survey. From there the user takes the sleep survey, which has the ability to assess their most likely sleep problem or problems from a list of seven sleep problem categories based upon their responses. At the end of the survey, participants will get information about which problem category they will fall into, and the level of certainty around that.
The purpose of the study is to determine the accuracy of the questionnaire in identifying the correct sleep problem when compared with the assessment of a sleep physician in a clinical sleep center. We hope to enroll 200 participants which was based upon an Initial power analyses were completed using pilot data, assuming accuracy rates of 70, 80, and 90% and a total sample size of 200. The intervals would be about ± 4.5% (for 90%) to ± 7% (for 70%). Participants will complete the survey, be blinded to the results, and then have a consultation with a sleep physician who will make an independent assessment.
- Conditions
- Sleep
- Being tested
- Sleep survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep surveyOther
The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry [including Philips]).
| Study group | Role | What they receive |
|---|---|---|
| Problem Sleepers | Those individuals that have self identified as having a unspecified sleep problem will take the sleep survey. Receives: Other: Sleep survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification
The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification. Percent agreement will be calculated for each sleep problem, and for the study sample as a whole, including the 95% confidence interval (CI).
Measured: 1 day
Secondary outcomes (1)
Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications.
Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications. This will be calculated for each sleep problem, and for the study sample as a whole, including the 95% confidence interval.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start19 Jun 2018
- Primary completion7 Sep 2018
- Study completion7 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cooperative Research Center (CRC) for Alertness, Safety and Productivity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590795
- Sponsor's protocol ID
- SRC-AI-SC-2018-10138
- Status last verified
- Sep 2018
- First submitted
- 10 Jul 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data sets will be shared with academic institutions for development purposes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
- ClinicalTrials.gov ID
- NCT03590795
- Acronym / sponsor ID
- SRC-AI-SC-2018-10138
- Conditions
- Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Collaborators
- Cooperative Research Center (CRC) for Alertness, Safety and Productivity
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 18 Jul 2018 (actual)
- 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.
Sleep is an important contributing factor to people's health. However, over one third of the general population has sleep complaints, causing both health related problems, and economic impact. Many do not think their problem sleep is serious enough to consult a physician (primary care or sleep specialist). For a selection of this population, self-tracking devices can be a solution, but these trackers are often activity based and therefore lacking in their capacity to give insight into underlying causes of poor quality sleep and daytime fatigue.
A new options for these confused sleeper is an online questionnaire, developed by Philips and Cooperative Research Center (CRC) for Alertness, Safety and Productivity Imagine a troubled sleeper awake at 3 am, they search "Why can't I sleep?" and find the survey. From there the user takes the sleep survey, which has the ability to assess their most likely sleep problem or problems from a list of seven sleep problem categories based upon their responses. At the end of the survey, participants will get information about which problem category they will fall into, and the level of certainty around that.
The purpose of the study is to determine the accuracy of the questionnaire in identifying the correct sleep problem when compared with the assessment of a sleep physician in a clinical sleep center. We hope to enroll 200 participants which was based upon an Initial power analyses were completed using pilot data, assuming accuracy rates of 70, 80, and 90% and a total sample size of 200. The intervals would be about ± 4.5% (for 90%) to ± 7% (for 70%). Participants will complete the survey, be blinded to the results, and then have a consultation with a sleep physician who will make an independent assessment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Problem Sleepers | – | Other: Sleep surveyThose individuals that have self identified as having a unspecified sleep problem will take the sleep survey. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be those who are new patients to the sleep lab or those recruited from a central recruiter that may or may not have sleep issues.
Key inclusion criteria (3 listed)
- Age: 20-75 years old.
- Able to provide written informed consent
- Able to read, write and speak English
Key exclusion criteria (4 listed)
- Has seen a sleep physician previously for formal clinical evaluation of a potential sleep problem.
- Is being treated for any sleep disorder.
- Has a major psychiatric disorder that is unstable at the time of evaluation.
- Has a major medical condition likely to contribute to and thus to confound any sleep problem (congestive heart failure, severe Chronic Obstructive Pulmonary Disease (COPD), a pain syndrome, etc).
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 |
|---|---|---|
| Sleep surveyThe Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry [including Philips]). | Other | Problem Sleepers |
Primary outcome
The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification
Time frame: 1 day
The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification. Percent agreement will be calculated for each sleep problem, and for the study sample as a whole, including the 95% confidence interval (CI).
1 secondary outcome
Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Individual participant dataSharing planned: Yes. De-identified data sets will be shared with academic institutions for development purposes
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Healthy Adult Participants
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Philips Respironics at 6 sites 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 4 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: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification (time frame: 1 day). 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 21 Sep 2018.