Sleep Apnea, Central, Sleep Apnea, Obstructive
Conditions
Brief summary
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.
Interventions
DEVICEDreamKit
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.
Sponsors
Pulmonary Critical Care Associates of Baltimore
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath Amplitude Correlation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Validation Arm |
|---|---|
| Age, Continuous | 30.3 years STANDARD_DEVIATION 14.9 |
| Body Mass Index (BMI) | 27.2 kg/m^2 STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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.
Time frame: Baseline
Population: 1 participant was excluded from the data analysis due to bad signal quality indicated by the DreamKit Home Sleep Test device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Validation Arm | Breath Amplitude Correlation | .66 ICC the aggregated signal amplitudes |