CompletedNCT04671342Updated Jan 31, 2023Results posted

DreamKit Diagnostic Validation

An interventional study of DreamKit in Sleep Apnea, Obstructive and Sleep Apnea, Central, sponsored by Philips Clinical & Medical Affairs Global. Completed at 7 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Philips Clinical & Medical Affairs Global · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 306
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.

Read the 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.

Conditions studied

Sleep Apnea, Obstructive
Sleep Apnea, Central

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In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 306 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Philips Clinical & Medical Affairs Global is the lead sponsor of 82 studies on the registry; 24 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Aged ≥18 years;
Fluent in English;
Able to provide informed consent.

Exclusion criteria

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).

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 306 participants (actual)

Study arms

Experimental
Validation Arm
Participants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard).
Device: DreamKit

Interventions

DeviceDreamKit
The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.

What researchers measure

Primary outcomes

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)

Secondary outcomes

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)

Results

Posted Jan 31, 2023

Participant flow

Total participants that were consented.

Consented and Screened (Visit 1)

Participant flow — Consented and Screened (Visit 1)
Milestone	DreamKit Device Intervention
Started	306
Completed	259
Not completed	47
Withdrew: Screen failure	3
Withdrew: Lost to follow-up	4
Withdrew: Withdrawal by subject	1
Withdrew: Withdrawn by sponsor due to recruitment consideration (csa patients)	39

Completed Visit 2 With Evaluable Data

Participant flow — Completed Visit 2 With Evaluable Data
Milestone	DreamKit Device Intervention
Started	259
Completed	200
Not completed	59
Withdrew: Unusable device data	58
Withdrew: Unusable psg data	1

Outcome measures

PrimaryIntraclass 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)
Reported as:: Number · intraclass correlation coefficient (ICC)

Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
intraclass correlation coefficient (ICC)	Validation Arm
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index	0.964 (0.953 to 0.973)

SecondaryIntraclass 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)
Reported as:: Number · intraclass correlation coefficient (ICC)

Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
intraclass correlation coefficient (ICC)	Validation Arm
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index	0.731 (0.659 to 0.790)

Adverse events

Collected over Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Validation Arm	0/306 (0%)	0/306 (0%)	7/306 (2.3%)

Most frequent other events

Most frequent other events
Event	Validation Arm
Upper Airway Dryness alleged from not using their CPAP therapyRespiratory, thoracic and mediastinal disorders	2/306
Side Effects from COVID vaccineGeneral disorders	1/306
Mouth/Tongue DrynessRespiratory, thoracic and mediastinal disorders	1/306
Struck head during PSGInjury, poisoning and procedural complications	1/306
Muscle strain due to exerciseMusculoskeletal and connective tissue disorders	1/306
Left Ear Pain due to Electrode placementEar and labyrinth disorders	1/306

Baseline characteristics

All participants that were consented

Age, Continuous
Age, Continuous(years)	Validation Arm
Mean	48.7 ± 15.3

Sex: Female, Male
Sex: Female, Male(Participants)	Validation Arm
Female	123
Male	174

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Validation Arm
Hispanic or Latino	45
Not Hispanic or Latino	251
Unknown or Not Reported	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Validation Arm
American Indian or Alaska Native	3
Asian	4
Native Hawaiian or Other Pacific Islander	1
Black or African American	29
White	262
More than one race	0
Unknown or Not Reported	1

Region of Enrollment
Region of Enrollment(participants)	Validation Arm
United States	297

Study locations

7 sites

Sleep Disorders Center of Alabama
Birmingham, Alabama 35213, United States
Delta Waves, Inc.
Colorado Springs, Colorado 80918, United States
Florida Lung and Sleep Associates
Lehigh Acres, Florida 33971, United States
Pulmonary and Critical Care Association of Baltimore
Towson, Maryland 21286, United States
Clayton Sleep Institute
Maplewood, Missouri 63143, United States
Berks Schuylkill Respiratory Specialists
Wyomissing, Pennsylvania 19610, United States
Bogan Sleep Consultants
Columbia, South Carolina 29201, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 26, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04671342
Lead sponsor: Philips Clinical & Medical Affairs Global
Responsible party: Sponsor
First posted: Dec 17, 2020
Start date: Jan 14, 2021
Primary completion: Dec 18, 2021
Completion: Dec 18, 2021
Results posted: Jan 31, 2023
Last update: Jan 31, 2023

Study contacts

Bill Hardy

study director · Philips Sleep & Respiratory Care

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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