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

NCT03468400 | Completed

• 1 other identifier: Dayzz
• Study Type: observational
• Target: 250
• Locations: 2 countries
• Sites: 2

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.

Conditions

Sleep Apnea Syndromes; Insomnia; Insufficient Sleep Syndrome; Circadian Rhythm Disorders

Keywords

sleep disorders; assessment; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A general community population and clinical population physician-referred for diagnosis and assessment of sleep disorders at a sleep clinic within a large medical center.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dayzz Live Well Ltd.: lead

Study Sites (2)

John Hopkins University

Baltimore, Maryland, 21224, United States

Location

Carmel Hospital

Haifa, 3436212, Israel

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Sleep Deprivation; Chronobiology Disorders; Sleep Wake Disorders; Disease

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 16, 2018
• Study Start: March 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

US (1); IL (1)