Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, OSA, AutoPAP, PAP, sleep disordered breathing, CPAP, Apnea hypopnea index, AHI
Brief summary
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.
Detailed description
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.
Interventions
DEVICESomnetics Transcend Auto
DEVICERespironics REMstar Auto with C-Flex
Sponsors
Somnetics International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult 18 years of age or older * Diagnosis of obstructive sleep apnea * Presently using CPAP or APAP therapy
Exclusion criteria
* Central or mixed apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Apnea Hypopnea Index (AHI) During Treatment | first and second night sleep study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unanticipated Adverse Device Effects | first and second night sleep study | Patients will be monitored for unanticipated adverse device effects during each sleep study. Patients will not be followed after the second sleep study. |
| Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI) | first and second night sleep study | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Patients Baseline characteristics were collected for all patients and were not analyzed by treatment arm | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | inadequate sleep study | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 51 Years STANDARD_DEVIATION 10.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
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.
Time frame: first and second night sleep study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcend | Mean Apnea Hypopnea Index (AHI) During Treatment | 2.1 AHI | Standard Deviation 2 |
| REMStar | Mean Apnea Hypopnea Index (AHI) During Treatment | 2.0 AHI | Standard Deviation 2.4 |
Comparison: Hypothesis testing for the primary endpoint was conducted using a one-sided test of non-inferiority with the following null and alternative hypotheses at the 0.05 significance level using the MIXED procedure in SAS, version 9.3:~H\_0:(ϕ\_m ) ̂≥6.9 H\_A:(ϕ\_m ) ̂\<6.9 where (ϕ\_m ) ̂ is the estimated AHI difference between Transcend Auto and REMstar Auto from the model described in 3.5.1.p-value: 0.05t-test, 1 sided
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.
Time frame: first and second night sleep study
Population: Hypopnea index (HI)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcend | Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI) | -0.7 units on a scale | Standard Deviation 2.3 |
| REMStar | Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI) | 0.2 units on a scale | Standard Deviation 1.6 |
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.
Time frame: first and second night sleep study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcend | Unanticipated Adverse Device Effects | 0 Participants |
| REMStar | Unanticipated Adverse Device Effects | 0 Participants |