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

NCT ID: NCT03468400

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Sleep Apnea Syndromes Insomnia Insufficient Sleep Syndrome Circadian Rhythm Disorders

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dayzz Live Well Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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John Hopkins University

Baltimore, Maryland, United States

Site Status

Carmel Hospital

Haifa, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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Dayzz

Identifier Type: -

Identifier Source: org_study_id

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