ClinicalTrials.gg
CompletedNCT03468400Updated Jul 22, 2020

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

An observational study in Sleep Apnea Syndromes, Insomnia and Insufficient Sleep Syndrome, sponsored by Dayzz Live Well Ltd.. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Dayzz Live Well Ltd. · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
250
Ages
21 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 369 studies in Sleep Apnea Syndromes with a site in United States — 49 open to participants now, 60 under way, 3 of them phase 3. Sleep Apnea Syndromes · United States.

Enrollment
28th of 82
250 · median 114
Started
2018
with 16 others
Observational
82 of 369
9 open now
Registered
231st of 369
by date

Among the 369 studies in Sleep Apnea Syndromes with a site in United States, this one is the 28th largest by enrollment of the 82 observational ones, is one of 17 that started in 2018, is one of 82 observational ones, and was the 231st registered.

By phase

369 studies; the count open now beside each. This study's row is marked.

No phase193 · 22 open
Observationalthis study82 · 9 open
Phase 228 · 3 open
Phase 420 · 7 open
Phase 115 · 2 open
Phase 315 · 3 open
Phase 1/210 · 3 open
Phase 2/36 · 0 open

By the year they started

First in 1998; this study’s year is marked. 17 started in 2018.

Size and results

Median enrollment 62 across the 284 interventional studies, 114 across the 82 observational. Of the 268 that completed or were terminated, 134 (50%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 369 studies in Sleep Apnea Syndromes with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

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

Keywords

  • sleep disorders
  • assessment
  • diagnosis
04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: 30-60 minutes

07

Study locations

2 sites
  • John Hopkins University
    Baltimore, Maryland 21224, United States
  • Carmel Hospital
    Haifa, 3436212, Israel
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Sep 2019, 18 months.

Of 149 observational studies under Sleep Apnea Syndromes, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 83. This study's 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 16, 2018
StartActual
Mar 1, 2018
Primary completionActual
Sep 30, 2019
CompletionActual
Sep 30, 2019
Last update
Jul 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03468400
Lead sponsor
Dayzz Live Well Ltd.
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Mar 1, 2018
Primary completion
Sep 30, 2019
Completion
Sep 30, 2019
Last update
Jul 22, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion