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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468400
• Other study ID #: Dayzz
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Disease
• Insomnia
• Insufficient Sleep Syndrome
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Deprivation
• Sleep Wake Disorders
• Syndrome

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