Sleep Apnea, ObstructiveNCT04926077
DreamKit Respiratory Effort Signal Validation
A study testing DreamKit in people with Sleep Apnea, Obstructive and Sleep Apnea, Central, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal. 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 7 Oct 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
- Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
- Pregnancy or planned pregnancy during the study (self-reported);
- History of allergic reactions to medical adhesives;
- Known allergy to lidocaine;
- Known seizure disorder;
- Severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy;
Show all 10Show fewer
- Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms or dyspnea;
- At risk for excessive bleeding including use of anticoagulants;
- An employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips);
- An employee, or spouse of an employee, of Pulmonary \& Critical Care Associates of Baltimore.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21286
About this study
Official title: Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
Read the detailed description
The rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from DreamKit vs. the gold-standard esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.
- 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; however, this study is intended only to validate the respiratory effort signal and does not assess diagnostic performance.
| Study group | Role | What they receive |
|---|---|---|
| Validation Arm | Experimental | Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort. Receives: Device: DreamKit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Amplitude Correlation
The primary endpoint is the intraclass correlation coefficient (ICC) of the peak-to-peak breath amplitude sequences extracted from the DreamKit and esophageal manometry respiratory effort signals during periods of occluded inspiration, end-expiratory breath holds, increased inspiratory resistance, increased expiratory resistance, and unresisted shallow breathing. The DreamKit Home Sleep Test device's effort signal is an uncalibrated signal. The amplitudes derived from the DreamKit Home Sleep Test device's effort signal were scaled for each subject to have the same variance across all tested breathing maneuvers. The lower-bound of the CI was compared against a target of 0.5.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start22 Jun 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pulmonary Critical Care Associates of Baltimore
- Responsible party
- Sponsor
- Investigators
- Alan Schwartz, MD, Principal investigator, Pulmonary Critical Care Associates of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926077
- Sponsor's protocol ID
- SRC_SLE_SparkleEP2_2021_11315
- Status last verified
- Nov 2022
- First submitted
- 8 Jun 2021
- Last updated
- 30 Nov 2022
- 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 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure
- ClinicalTrials.gov ID
- NCT04926077
- Acronym / sponsor ID
- SRC_SLE_SparkleEP2_2021_11315
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Central
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Pulmonary Critical Care Associates of Baltimore
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Posted 30 Nov 2022
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 the validity of the DreamKit respiratory effort signal.
Detailed description
The rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from DreamKit vs. the gold-standard esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.
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 an esophageal manometry catheter (reference standard) to record respiratory effort. |
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 (10 listed)
- Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
- Pregnancy or planned pregnancy during the study (self-reported);
- History of allergic reactions to medical adhesives;
- Known allergy to lidocaine;
- Known seizure disorder;
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; however, this study is intended only to validate the respiratory effort signal and does not assess diagnostic performance. | Device | Validation Arm |
Primary outcome
Breath Amplitude Correlation
Time frame: Baseline
The primary endpoint is the intraclass correlation coefficient (ICC) of the peak-to-peak breath amplitude sequences extracted from the DreamKit and esophageal manometry respiratory effort signals during periods of occluded inspiration, end-expiratory breath holds, increased inspiratory resistance, increased expiratory resistance, and unresisted shallow breathing. The DreamKit Home Sleep Test device's effort signal is an uncalibrated signal. The amplitudes derived from the DreamKit Home Sleep Test device's effort signal were scaled for each subject to have the same variance across all tested breathing maneuvers. The lower-bound of the CI was compared against a target of 0.5.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- 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.
Alan Schwartz, MD principal investigator
Pulmonary Critical Care Associates of Baltimore
1 site 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 1 site 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 10 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 30 Nov 2022). 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?
Breath Amplitude Correlation (time frame: Baseline). 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 30 Nov 2022.