N/A
N=11
DreamKit Respiratory Effort Signal Validation
Sleep Apnea, Obstructive · Sleep Apnea, Central
Bottom Line
View on ClinicalTrials.gov: NCT04926077 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Breath Amplitude Correlation — .66 ICC the aggregated signal amplitudes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DreamKit (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breath Amplitude Correlation |
.66 | — |
Summary
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
Eligibility Criteria
Inclusion Criteria
- Aged ≥18 years;
- Fluent in English;
- Able to provide informed consent.
Exclusion Criteria
- 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;
- 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.
Data sourced from ClinicalTrials.gov (NCT04926077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.