Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire

Sponsor

Dayzz Live Well Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03468400

Collaborator

(none)

250

Enrollment

Locations

Actual Duration (Months)

125

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to develop and test a user-friendly, accessible approach to sleep assessment which can function as an initial "triage" of targeted sleep conditions, such as insomnia, insufficient sleep syndrome, sleep apnea syndromes/snoring, and circadian sleep/wake disorders, within the clinical and community population. Specifically, this study will test the validity and reliability of a self-rated, digitized, and cost-effective diagnostic measure with sufficient sensitivity to accurately assess/diagnose common sleep conditions and/or risk for these conditions. Such an approach, would allow for faster assessment of common sleep conditions and disorders, and provide clinical knowledge to the individual, the physician, and if required insurance companies, as to those persons who need more immediate attention or treatment for their sleep condition.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes Insomnia Insufficient Sleep Syndrome Circadian Rhythm Disorders

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Outcome Measures

Primary Outcome Measures

Sleep disorders diagnosis and severity of diagosis [30-60 minutes]
Dayzz diagnostic sleep questionnaire (dDSQ): Insomnia, insufficient sleep syndrome, circadian sleep/wake disorders, risk for sleep apnea, snoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients aged 21-65 years who are referred to the sleep clinic at Carmel Medical Center and who are capable of filling out an electronic questionnaire in Hebrew.

Exclusion Criteria:

Patient age <21 years or >65 years.
Women who are pregnant or breastfeeding.
Nighttime shift-workers.
Persons who are unable to provide consent due to mental incapacity.
Persons referred for evaluation by Ministry of Transportation (for licensing purposes).