Obstructive Sleep ApneaNCT01171066
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
A study testing Tasman CPAP system in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
Trial summary
Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Tasman CPAP system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients being treated for OSA for >6 months
- Patients using a ResMed nasal mask system
- Patients who can trial the trial mask for 7 nights
Who cannot join
- Patients not willing to give written informed consent
- Patients who can not read and comprehend English
- Patients being treated for OSA for <6 months
- Patients using an inappropriate mask system
- Patients using Bilevel flow generators
- Patients who are not using CPAP between 7 and 13 cmH2O
Show all 9Show fewer
- Patients who are pregnant
- Patients who cannot trial the trial mask for 7 nights
- Patients with a hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea
Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
Read the detailed description
Obstructive Sleep Apnoea (OSA) is a condition characterised by partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit.
Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up.
The purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
Aim
- To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
- To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Tasman CPAP system
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasman CPAP systemDevice
Also called ResMed Tasman
Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.
| Study group | Role | What they receive |
|---|---|---|
| Tasman CPAP | Experimental | Not described Receives: Device: Tasman CPAP system |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
Measured: 1 week
Secondary outcomes (1)
To assess the usability of the Tasman CPAP system
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Schindhelm, Principal investigator, ResMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171066
- Sponsor's protocol ID
- MA14010
- Status last verified
- Feb 2021
- First submitted
- 26 Jul 2010
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01171066
- Acronym / sponsor ID
- MA14010
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
Detailed description
Obstructive Sleep Apnoea (OSA) is a condition characterised by partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit.
Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up.
The purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
Aim
- To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
- To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tasman CPAP | Experimental | Device: Tasman CPAP system |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients being treated for OSA for >6 months
- Patients using a ResMed nasal mask system
- Patients who can trial the trial mask for 7 nights
Key exclusion criteria (9 listed)
- Patients not willing to give written informed consent
- Patients who can not read and comprehend English
- Patients being treated for OSA for <6 months
- Patients using an inappropriate mask system
- Patients using Bilevel flow generators
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 |
|---|---|---|
| Tasman CPAP systemAlso: ResMed TasmanParticipants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system. | Device | Tasman CPAP |
Primary outcome
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
Time frame: 1 week
1 secondary outcome
To assess the usability of the Tasman CPAP system
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Klaus Schindhelm principal investigator
ResMed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tasman CPAP system in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
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 5 inclusion and 9 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape) (time frame: 1 week). 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 4 Feb 2021.