Obstructive Sleep ApneaNCT01799265
Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
A study testing Somnetics Transcend Auto and Respironics REMstar Auto with C-Flex in people with Obstructive Sleep Apnea, run by Somnetics International, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Somnetics Transcend Auto and Respironics REMstar Auto with C-Flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2013to 10 Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years of age or older
- Diagnosis of obstructive sleep apnea
- Presently using CPAP or APAP therapy
Who cannot join
- Central or mixed apnea
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwind Lung Specialists and Sleep Center
Coon Rapids, Minnesota, 55433
Whitney Sleep Center
Plymouth, Minnesota, 55441
Sleep Therapy and Research Center
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Somnetics Transcend Auto, Respironics REMstar Auto with C-Flex
- Keywords
- obstructive sleep apnea, OSA, AutoPAP, PAP, sleep disordered breathing, CPAP, Apnea hypopnea index, AHI
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somnetics Transcend AutoDevice
Respironics REMstar Auto with C-FlexDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Somnetics Transcend Auto; Device: Respironics REMstar Auto with C-Flex |
| 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. Receives: Device: Somnetics Transcend Auto; Device: Respironics REMstar Auto with C-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first and second night sleep study
Secondary outcomes (2)
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.
Measured: first and second night sleep study
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.
Measured: first and second night sleep study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study start27 Feb 2013
- Primary completion10 Jun 2013
- Study completion10 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somnetics International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Powell, PhD RPSGT, Principal investigator, Sleep Therapy and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799265
- Sponsor's protocol ID
- 800383
- Status last verified
- Oct 2022
- First submitted
- 19 Feb 2013
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT01799265
- Acronym / sponsor ID
- 800383
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, OSA, AutoPAP, PAP, sleep disordered breathing, CPAP, Apnea hypopnea index, AHI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Somnetics International, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2013
- Primary completion
- 10 Jun 2013 (actual)
- Study completion
- 10 Jun 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcend followed by REMstar | Active comparator | Device: Somnetics Transcend Auto, Device: Respironics REMstar Auto with C-FlexThe patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night. |
| REMstar followed by Transcend | Active comparator | Device: Somnetics Transcend Auto, Device: Respironics REMstar Auto with C-FlexThe patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult 18 years of age or older
- Diagnosis of obstructive sleep apnea
- Presently using CPAP or APAP therapy
Key exclusion criteria (1 listed)
- Central or mixed apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somnetics Transcend Auto | Device | REMstar followed by Transcend, Transcend followed by REMstar |
| Respironics REMstar Auto with C-Flex | Device | REMstar followed by Transcend, Transcend followed by REMstar |
Primary outcome
Mean Apnea Hypopnea Index (AHI) During Treatment
Time frame: 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.
2 secondary outcomes
Unanticipated Adverse Device Effects
Time frame: first and second night sleep study
Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)
Time frame: first and second night sleep study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Powell, PhD RPSGT principal investigator
Sleep Therapy and Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somnetics Transcend Auto and Respironics REMstar Auto with C-Flex in people with Obstructive Sleep Apnea, run by Somnetics International, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Apnea Hypopnea Index (AHI) During Treatment (time frame: first and second night sleep study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.