Sleep Apnea, ObstructiveNCT04630639
Sparkle Respiratory Effort Validation
A study testing Sparkle 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 Sparkle 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?
- Sparkle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2021to Jun 2021
- Phase
- Interventional
- 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 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;
- 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;
- Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms;
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- 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 and 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 Sparkle Respiratory Effort Signal Against Esophageal Pressure in Healthy Participants
This study has been developed in order to demonstrate the validity of the Sparkle respiratory effort signal.
Read the detailed description
The rationale for undertaking this study is to demonstrate that the agreement between the Sparkle respiratory effort signal amplitude and esophageal manometry is non-inferior to the agreement between the thoracic belt respiratory effort signal amplitude and esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the Sparkle device, respiratory belts, 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
- Sparkle
- 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.
SparkleDevice
The Sparkle 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 Sparkle device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort. Receives: Device: Sparkle |
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 average correlation co-efficient of the breath amplitude sequences extracted from the Sparkle and esophageal manometry respiratory effort signals, with respect to the average correlation co-efficient of the breath amplitude sequences extracted from the thoracic belt and esophageal manometry respiratory effort signals.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study startMar 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Changed scientific strategy. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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 and Critical Care Associates of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630639
- Sponsor's protocol ID
- SRC-NBS-Sparkle-EP-2019-10456
- Status last verified
- Jun 2021
- First submitted
- 9 Nov 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- 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 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Sparkle Respiratory Effort Signal Against Esophageal Pressure in Healthy Participants
- ClinicalTrials.gov ID
- NCT04630639
- Acronym / sponsor ID
- SRC-NBS-Sparkle-EP-2019-10456
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Central
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changed scientific strategy. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Pulmonary Critical Care Associates of Baltimore
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Nov 2020 (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.
This study has been developed in order to demonstrate the validity of the Sparkle respiratory effort signal.
Detailed description
The rationale for undertaking this study is to demonstrate that the agreement between the Sparkle respiratory effort signal amplitude and esophageal manometry is non-inferior to the agreement between the thoracic belt respiratory effort signal amplitude and esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the Sparkle device, respiratory belts, 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: SparkleParticipants will wear the Sparkle 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 (9 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;
- 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;
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 |
|---|---|---|
| SparkleThe Sparkle 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 average correlation co-efficient of the breath amplitude sequences extracted from the Sparkle and esophageal manometry respiratory effort signals, with respect to the average correlation co-efficient of the breath amplitude sequences extracted from the thoracic belt and esophageal manometry respiratory effort signals.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- 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 and 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 Sparkle 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 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: withdrawn, as of the sponsor's last update on 23 Jun 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 23 Jun 2021.