Trial Outcomes & Findings for DreamKit Respiratory Effort Signal Validation (NCT NCT04926077)
NCT ID: NCT04926077
Last Updated: 2022-11-30
Results Overview
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.
COMPLETED
NA
11 participants
Baseline
2022-11-30
Participant Flow
Participant milestones
| Measure |
Validation Arm
Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort.
DreamKit: 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.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DreamKit Respiratory Effort Signal Validation
Baseline characteristics by cohort
| Measure |
Validation Arm
n=11 Participants
Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort.
DreamKit: 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.
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Age, Continuous
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30.3 years
STANDARD_DEVIATION 14.9 • n=99 Participants
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Sex: Female, Male
Female
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6 Participants
n=99 Participants
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Sex: Female, Male
Male
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5 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=99 Participants
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Race (NIH/OMB)
White
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6 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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11 participants
n=99 Participants
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Body Mass Index (BMI)
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27.2 kg/m^2
STANDARD_DEVIATION 6.7 • n=99 Participants
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PRIMARY outcome
Timeframe: BaselinePopulation: 1 participant was excluded from the data analysis due to bad signal quality indicated by the DreamKit Home Sleep Test device.
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.
Outcome measures
| Measure |
Validation Arm
n=10 Participants
Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort.
DreamKit: 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.
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Breath Amplitude Correlation
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.66 ICC the aggregated signal amplitudes
Interval 0.64 to 0.67
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Adverse Events
Validation Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place