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This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Validation Arm | Experimental | Participants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DreamKit | Device | The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (within six weeks of enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bill Hardy | Philips Sleep & Respiratory Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Delta Waves, Inc. |
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Total participants that were consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consented and Screened (Visit 1) |
|
| ||||||||||||||||||||||||
| Completed Visit 2 With Evaluable Data |
|
All participants that were consented
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Completed Visit 2 with evaluable data | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | Visit 2 (within six weeks of enrollment) |
|
Throughout the individual's participation in the study, (Visit 1 and Visit 2) and up to 7 days after completing visit 2
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side Effects from COVID vaccine | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bill Hardy | Philips | 412-874-2710 | bill.hardy@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2021 | Dec 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Visit 2 (within six weeks of enrollment) |
| 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 |
| Withdrawn by sponsor due to recruitment consideration (CSA patients) |
|
|
| years |
|
| Sex: Female, Male | Baseline data (Sex) available for 297 of 306 participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Baseline data (Ethnicity) available for 297 of 306 participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline data (Race) available for 300 of 306 participants. | Count of Participants | Participants |
|
| Region of Enrollment | Demographic information only available and analyzed for 297 out of 306 participants. All enrollment occurred in the United States. | Number | participants |
|
|
|
| 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. | Completed Visit 2 with evaluable data | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | Visit 2 (within six weeks of enrollment) |
|
|
|
| 0 |
| 306 |
| 0 |
| 306 |
| 7 |
| 306 |
| Upper Airway Dryness alleged from not using their CPAP therapy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Mouth/Tongue Dryness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Struck head during PSG | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle strain due to exercise | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Left Ear Pain due to Electrode placement | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |