Sleep Apnea SyndromesNCT03468400
Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire
An observational study of Sleep Apnea Syndromes and Insomnia, run by Dayzz Live Well Ltd. at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes, Insomnia, Insufficient Sleep Syndrome
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Keywords
- sleep disorders, assessment, diagnosis
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Chronobiology Disorders, Sleep Wake Disorders, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dayzz Live Well Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468400
- Sponsor's protocol ID
- Dayzz
- Status last verified
- Jul 2020
- First submitted
- 12 Mar 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire
- ClinicalTrials.gov ID
- NCT03468400
- Acronym / sponsor ID
- Dayzz
- Keywords
- sleep disorders, assessment, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Dayzz Live Well Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep disorders diagnosis and severity of diagosis
Time frame: 30-60 minutes
Dayzz diagnostic sleep questionnaire (dDSQ): Insomnia, insufficient sleep syndrome, circadian sleep/wake disorders, risk for sleep apnea, snoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Related trials for Sleep Apnea Syndromes
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes and Insomnia, run by Dayzz Live Well Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disorders diagnosis and severity of diagosis (time frame: 30-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.