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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3436212
    • Carmel Hospital
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • John Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dayzz Live Well Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (ACTUAL): March 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: diagnosis; assessment; sleep disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Apnea Syndromes; Syndrome; Disease; Sleep Wake Disorders; Parasomnias; Sleep Deprivation; Chronobiology Disorders
• Other Study ID Numbers: Dayzz

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No