Sleep Apnea, Central, Sleep Apnea, Obstructive
Conditions
Brief summary
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
Detailed description
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.
Interventions
DEVICEDreamKit
The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.
Sponsors
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
* Self-reported habitual sleep duration of \<4 hours/night on average (How many hours sleep do you usually get per night?); * Circadian phase disorder, shift work, or any other issue/condition that would, in the opinion of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the overnight study; * History of allergic reactions to medical adhesives; * Skin rash or other dermatological condition that would impact correct placement of the DreamKit device and/or PSG sensors, and/or would be exacerbated by the presence of the device or sensors; * Presence of a pacemaker; * Severe medical condition (controlled or uncontrolled) that would impede data collection in the opinion of the site investigator, including the requirement for oxygen therapy; * \[for those currently using overnight therapy\]: Unwilling to withdraw from overnight therapy for a single night and/or clinically unsuitable to withdraw from overnight therapy in the opinion of the site investigator, with overnight therapy including but not limited to any form of PAP or ventilation, oral device including mandibular advancement devices or mouthguard for bruxism, nasal dilator strips, and/or positional device; * \[for those currently using overnight therapy\]: Considered by the site investigator to be at risk of an AE resulting from hypersomnolence the day after the overnight visit, such as a high-risk occupation including but not limited to a pilot or commercial driver; * An employee, or family member of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index | Visit 2 (within six weeks of enrollment) | The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraclass Correlation Coefficient (ICC) of the Central Apnea Index | Visit 2 (within six weeks of enrollment) | The secondary endpoint is the ICC for absolute agreement between the PSG-central apnea index (CAI) and the DreamKit-CAI. The higher ICC indicates higher correlation/agreement between the PSG CAII and DreamKit CAI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient. |
Countries
United States
Participant flow
Recruitment details
Total participants that were consented.
Participants by arm
| Arm | Count |
|---|---|
| Validation Arm Participants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard).
DreamKit: The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing. | 306 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Completed Visit 2 With Evaluable Data | Unusable device data | 58 |
| Completed Visit 2 With Evaluable Data | Unusable PSG data | 1 |
| Consented and Screened (Visit 1) | Lost to Follow-up | 4 |
| Consented and Screened (Visit 1) | Screen Failure | 3 |
| Consented and Screened (Visit 1) | Withdrawal by Subject | 1 |
| Consented and Screened (Visit 1) | Withdrawn by sponsor due to recruitment consideration (CSA patients) | 39 |
Baseline characteristics
| Characteristic | Validation Arm |
|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 251 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 262 Participants |
| Region of Enrollment United States | 297 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 306 |
| other Total, other adverse events | 7 / 306 |
| serious Total, serious adverse events | 0 / 306 |
Outcome results
Primary
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Time frame: Visit 2 (within six weeks of enrollment)
Population: Completed Visit 2 with evaluable data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Validation Arm | Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index | 0.964 intraclass correlation coefficient (ICC) |
Secondary
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
The secondary endpoint is the ICC for absolute agreement between the PSG-central apnea index (CAI) and the DreamKit-CAI. The higher ICC indicates higher correlation/agreement between the PSG CAII and DreamKit CAI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Time frame: Visit 2 (within six weeks of enrollment)
Population: Completed Visit 2 with evaluable data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Validation Arm | Intraclass Correlation Coefficient (ICC) of the Central Apnea Index | 0.731 intraclass correlation coefficient (ICC) |