Sleep Apnea, ObstructiveNCT04671342
DreamKit Diagnostic Validation
A study testing DreamKit in people with Sleep Apnea, Obstructive and Sleep Apnea, Central, run by Philips Clinical & Medical Affairs Global at 7 sites in United States.
Trial summary
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep Apnea, Central
- What is being tested?
- DreamKit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Jan 2021to 18 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years;
- Fluent in English;
- Able to provide informed consent.
Who cannot join
- Self-reported habitual sleep duration of <4 hours/night on average ("How many hours sleep do you usually get per night?");
- Circadian phase disorder, shift work, or any other issue/condition that would, in the opinion of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the overnight study;
- History of allergic reactions to medical adhesives;
- Skin rash or other dermatological condition that would impact correct placement of the DreamKit device and/or PSG sensors, and/or would be exacerbated by the presence of the device or sensors;
- Presence of a pacemaker;
- Severe medical condition (controlled or uncontrolled) that would impede data collection in the opinion of the site investigator, including the requirement for oxygen therapy;
Show all 9Show fewer
- [for those currently using overnight therapy]: Unwilling to withdraw from overnight therapy for a single night and/or clinically unsuitable to withdraw from overnight therapy in the opinion of the site investigator, with overnight therapy including but not limited to any form of PAP or ventilation, oral device including mandibular advancement devices or mouthguard for bruxism, nasal dilator strips, and/or positional device;
- [for those currently using overnight therapy]: Considered by the site investigator to be at risk of an AE resulting from hypersomnolence the day after the overnight visit, such as a high-risk occupation including but not limited to a pilot or commercial driver;
- An employee, or family member of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Delta Waves, Inc.
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants
Columbia, South Carolina, 29201
Florida Lung and Sleep Associates
Lehigh Acres, Florida, 33971
Clayton Sleep Institute
Maplewood, Missouri, 63143
Pulmonary and Critical Care Association of Baltimore
Towson, Maryland, 21286
Berks Schuylkill Respiratory Specialists
Wyomissing, Pennsylvania, 19610
About this study
Official title: Diagnostic Validation of the DreamKit Device Against Polysomnography
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
Read the detailed description
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Central
- Being tested
- DreamKit
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreamKitDevice
The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.
| Study group | Role | What they receive |
|---|---|---|
| Validation Arm | Experimental | Participants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard). Receives: Device: DreamKit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Measured: Visit 2 (within six weeks of enrollment)
Secondary outcomes (1)
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
The secondary endpoint is the ICC for absolute agreement between the PSG-central apnea index (CAI) and the DreamKit-CAI. The higher ICC indicates higher correlation/agreement between the PSG CAII and DreamKit CAI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Measured: Visit 2 (within six weeks of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start14 Jan 2021
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bill Hardy, Study director, Philips Sleep & Respiratory Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671342
- Sponsor's protocol ID
- SRC_SLE_Sparkle_PSG_2020_10908
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2020
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Validation of the DreamKit Device Against Polysomnography
- ClinicalTrials.gov ID
- NCT04671342
- Acronym / sponsor ID
- SRC_SLE_Sparkle_PSG_2020_10908
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Central
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 31 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
Detailed description
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation Arm | Experimental | Device: DreamKitParticipants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years;
- Fluent in English;
- Able to provide informed consent.
Key exclusion criteria (9 listed)
- Self-reported habitual sleep duration of <4 hours/night on average ("How many hours sleep do you usually get per night?");
- Circadian phase disorder, shift work, or any other issue/condition that would, in the opinion of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the overnight study;
- History of allergic reactions to medical adhesives;
- Skin rash or other dermatological condition that would impact correct placement of the DreamKit device and/or PSG sensors, and/or would be exacerbated by the presence of the device or sensors;
- Presence of a pacemaker;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DreamKitThe DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing. | Device | Validation Arm |
Primary outcome
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
Time frame: Visit 2 (within six weeks of enrollment)
The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
1 secondary outcome
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
Time frame: Visit 2 (within six weeks of enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Bill Hardy study director
Philips Sleep & Respiratory Care
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DreamKit in people with Sleep Apnea, Obstructive and Sleep Apnea, Central, run by Philips Clinical & Medical Affairs Global at 7 sites in United States.
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 3 inclusion and 9 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index (time frame: Visit 2 (within six weeks of enrollment)). 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 31 Jan 2023.