Trial Outcomes & Findings for DreamKit Diagnostic Validation (NCT NCT04671342)
NCT ID: NCT04671342
Last Updated: 2023-01-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
306 participants
Primary outcome timeframe
Visit 2 (within six weeks of enrollment)
Results posted on
2023-01-31
Participant Flow
Total participants that were consented.
Participant milestones
| Measure |
DreamKit Device Intervention
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.
|
|---|---|
|
Consented and Screened (Visit 1)
STARTED
|
306
|
|
Consented and Screened (Visit 1)
COMPLETED
|
259
|
|
Consented and Screened (Visit 1)
NOT COMPLETED
|
47
|
|
Completed Visit 2 With Evaluable Data
STARTED
|
259
|
|
Completed Visit 2 With Evaluable Data
COMPLETED
|
200
|
|
Completed Visit 2 With Evaluable Data
NOT COMPLETED
|
59
|
Reasons for withdrawal
| Measure |
DreamKit Device Intervention
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.
|
|---|---|
|
Consented and Screened (Visit 1)
Screen Failure
|
3
|
|
Consented and Screened (Visit 1)
Lost to Follow-up
|
4
|
|
Consented and Screened (Visit 1)
Withdrawal by Subject
|
1
|
|
Consented and Screened (Visit 1)
Withdrawn by sponsor due to recruitment consideration (CSA patients)
|
39
|
|
Completed Visit 2 With Evaluable Data
Unusable device data
|
58
|
|
Completed Visit 2 With Evaluable Data
Unusable PSG data
|
1
|
Baseline Characteristics
Baseline data (Sex) available for 297 of 306 participants.
Baseline characteristics by cohort
| Measure |
Validation Arm
n=306 Participants
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.
|
|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 15.3 • n=306 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=297 Participants • Baseline data (Sex) available for 297 of 306 participants.
|
|
Sex: Female, Male
Male
|
174 Participants
n=297 Participants • Baseline data (Sex) available for 297 of 306 participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=297 Participants • Baseline data (Ethnicity) available for 297 of 306 participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
251 Participants
n=297 Participants • Baseline data (Ethnicity) available for 297 of 306 participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=297 Participants • Baseline data (Ethnicity) available for 297 of 306 participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=300 Participants • Baseline data (Race) available for 300 of 306 participants.
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=300 Participants • Baseline data (Race) available for 300 of 306 participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=300 Participants • Baseline data (Race) available for 300 of 306 participants.
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=300 Participants • Baseline data (Race) available for 300 of 306 participants.
|
|
Race (NIH/OMB)
White
|
262 Participants
n=300 Participants • Baseline data (Race) available for 300 of 306 participants.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=300 Participants • Baseline data (Race) available for 300 of 306 participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=300 Participants • Baseline data (Race) available for 300 of 306 participants.
|
|
Region of Enrollment
United States
|
297 participants
n=297 Participants • Demographic information only available and analyzed for 297 out of 306 participants. All enrollment occurred in the United States.
|
PRIMARY outcome
Timeframe: Visit 2 (within six weeks of enrollment)Population: Completed Visit 2 with evaluable data
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.
Outcome measures
| Measure |
Validation Arm
n=200 Participants
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.
|
|---|---|
|
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
|
0.964 intraclass correlation coefficient (ICC)
Interval 0.953 to 0.973
|
SECONDARY outcome
Timeframe: Visit 2 (within six weeks of enrollment)Population: Completed Visit 2 with evaluable data
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.
Outcome measures
| Measure |
Validation Arm
n=200 Participants
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.
|
|---|---|
|
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
|
0.731 intraclass correlation coefficient (ICC)
Interval 0.659 to 0.79
|
Adverse Events
Validation Arm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Validation Arm
n=306 participants at risk
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.
|
|---|---|
|
General disorders
Side Effects from COVID vaccine
|
0.33%
1/306 • Number of events 2 • Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Dryness alleged from not using their CPAP therapy
|
0.65%
2/306 • Number of events 2 • Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2
|
|
Respiratory, thoracic and mediastinal disorders
Mouth/Tongue Dryness
|
0.33%
1/306 • Number of events 1 • Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2
|
|
Injury, poisoning and procedural complications
Struck head during PSG
|
0.33%
1/306 • Number of events 1 • Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2
|
|
Musculoskeletal and connective tissue disorders
Muscle strain due to exercise
|
0.33%
1/306 • Number of events 1 • Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2
|
|
Ear and labyrinth disorders
Left Ear Pain due to Electrode placement
|
0.33%
1/306 • Number of events 1 • Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place