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N/A N=11 Diagnostic

DreamKit Respiratory Effort Signal Validation

Sleep Apnea, Obstructive · Sleep Apnea, Central

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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