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| Name | Class |
|---|---|
| Pulmonary Critical Care Associates of Baltimore | OTHER |
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This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Validation Arm | Experimental | Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort. |
|
| 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; however, this study is intended only to validate the respiratory effort signal and does not assess diagnostic performance. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Schwartz, MD | Pulmonary Critical Care Associates of Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary and Critical Care Associates of Baltimore | Baltimore | Maryland | 21286 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants that signed a consent form.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | 1 participant was excluded from the data analysis due to bad signal quality indicated by the DreamKit Home Sleep Test device. | Posted | Number | 95% Confidence Interval | ICC the aggregated signal amplitudes | Baseline |
|
4 weeks
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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 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. |
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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 | Jun 24, 2021 | Oct 7, 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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
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. |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |