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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03468400
Other study ID # Dayzz
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date September 30, 2019

Study information

Verified date July 2020
Source Dayzz Live Well Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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


Locations

Country Name City State
Israel Carmel Hospital Haifa
United States John Hopkins University Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Dayzz Live Well Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep disorders diagnosis and severity of diagosis Dayzz diagnostic sleep questionnaire (dDSQ): Insomnia, insufficient sleep syndrome, circadian sleep/wake disorders, risk for sleep apnea, snoring 30-60 minutes
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