VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)

Sleep Clinical Trial

Official title:

VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590795
• Other study ID #: SRC-AI-SC-2018-10138
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: September 7, 2018

Study information

• Verified date: September 2018
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: September 7, 2018
• Est. primary completion date: September 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 20-75 years old.

• Able to provide written informed consent

• Able to read, write and speak English

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Sleep

Intervention

Other:
• Sleep survey
The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry [including Philips]).

Locations

Country	Name	City	State
United States	NeuroTrials Research Inc.	Atlanta	Georgia
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	Florida Lung & Sleep Associates	Lehigh Acres	Florida
United States	Clayton Sleep Institute	Saint Louis	Missouri
United States	Sleep Therapy and Research Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Philips Respironics	Cooperative Research Center (CRC) for Alertness, Safety and Productivity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 day
Secondary	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.	1 day