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

Completed

• Conditions: Insufficient Sleep Syndrome; Circadian Rhythm Disorders; Sleep Apnea Syndromes; Insomnia

• Registration Number: NCT03468400
• Lead Sponsor: Dayzz Live Well Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-16
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Carmel Hospital; 🇮🇱 Haifa, Israel