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The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.
This is a prospective, randomized, crossover trial. Patients will be randomized 1:1 to undergo two full night sleep studies with the Transcend Auto and a commercially available device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcend followed by REMstar | Active Comparator | The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night. |
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| REMstar followed by Transcend | Active Comparator | The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somnetics Transcend Auto | Device |
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| Respironics REMstar Auto with C-Flex |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Apnea Hypopnea Index (AHI) During Treatment | Apnea hypopnea index (AHI) will be measured during treatment with each of the devices. AHI = (number of apneas + number of hypopneas) / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI >/= 15. AHI was measured by the devices and independently by a central laboratory. | first and second night sleep study |
| Measure | Description | Time Frame |
|---|---|---|
| Unanticipated Adverse Device Effects | Patients will be monitored for unanticipated adverse device effects during each sleep study. Patients will not be followed after the second sleep study. | first and second night sleep study |
| Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Powell, PhD RPSGT | Sleep Therapy and Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwind Lung Specialists and Sleep Center | Coon Rapids | Minnesota | 55433 | United States | ||
| Whitney Sleep Center |
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Sites screened individuals who were appropriate for study inclusion by chart review followed by telephone interview. Patients were then asked to schedule an office visit. If the screened individual met the selection criteria, and was interested in participation, the subject was asked to provide informed consent for participation. Subjects were considered enrolled in the study at the time of consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcend Auto Then REMstar Auto | Patients underwent first night sleep study with Transcend followed by second night sleep study with REMstar |
| FG001 | REMStar Then Transcend Auto |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Device |
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Mean hypopnea index will be measure during treatment. HI will be measured during treatment with each of the devices. HI = number of hypopneas / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI >/= 15. HI was measured by the devices and independently by a central laboratory. Results are reported as the Mean Differences between PSG and Device Hypopnea Index. These differences can be reported as negative values. |
| first and second night sleep study |
| Plymouth |
| Minnesota |
| 55441 |
| United States |
| Sleep Therapy and Research Center | San Antonio | Texas | 78229 | United States |
Patients underwent first night sleep study with REMStar and second night with Transcend Auto
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Baseline characteristics were collected for all patients and were not analyzed by treatment arm |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Apnea Hypopnea Index (AHI) During Treatment | Apnea hypopnea index (AHI) will be measured during treatment with each of the devices. AHI = (number of apneas + number of hypopneas) / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI >/= 15. AHI was measured by the devices and independently by a central laboratory. | Posted | Mean | Standard Deviation | AHI | first and second night sleep study |
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| Secondary | Unanticipated Adverse Device Effects | Patients will be monitored for unanticipated adverse device effects during each sleep study. Patients will not be followed after the second sleep study. | Posted | Count of Participants | Participants | first and second night sleep study |
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| Secondary | Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI) | Mean hypopnea index will be measure during treatment. HI will be measured during treatment with each of the devices. HI = number of hypopneas / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI >/= 15. HI was measured by the devices and independently by a central laboratory. Results are reported as the Mean Differences between PSG and Device Hypopnea Index. These differences can be reported as negative values. | Hypopnea index (HI) | Posted | Mean | Standard Deviation | units on a scale | first and second night sleep study |
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Patients were not followed after the second sleep study. Documentation of adverse events stopped after the second night's sleep study.
Low level headache-lightheaded.
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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 | Transcend | Transcend Arm | 0 | 20 | 1 | 20 | ||
| EG001 | REMStar | REMStar Arm | 0 | 21 | 0 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Non-systematic Assessment | headache and lightheadedness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Swanson | Bluebird Consulting | 6123084500 | melinda@bluebirddevice.com |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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