Obstructive Sleep Apnoea Hypopnoea SyndromeNCT00358800
REMStar Auto With C-Flex - In-Laboratory Performance v. Conventionally Titrated CPAP Therapy: Performances and Preferences
A study testing REMStar Auto with C-Flex in people with Obstructive Sleep Apnoea Hypopnoea Syndrome, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will evaluate the use of REMStar Auto with C-Flex (RSA C-Flex) therapy in subjects with previously diagnosed obstructive sleep apnea / hypopnea syndrome, during in-laboratory studies. The study will determine the ability of RSA C-Flex therapy to effectively treat the sleep apnea events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnoea Hypopnoea Syndrome
- What is being tested?
- REMStar Auto with C-Flex
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2005to Dec 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Primary medical diagnosis Obstructive Sleep Apnea / Hypopnea Syndrome
- AHI ≥ 15 events•hr-1 of sleep
- Ability to provide consent
- Successful completion of a conventional CPAP titration in a sleep laboratory under polysomnographic conditions (success defined by reduction of AHI to < 5•hr-1 during therapeutic portion of study, in supine position and in REM and NREM sleep state).
Who cannot join
- Patients who are medically complicated or who are medically unstable.
- Patients who have been on chronic CPAP or BiPAP therapy or require oxygen therapy.
- Patients with respiratory failure or respiratory insufficiency or who have elevated arterial carbon dioxide levels while awake.
- Patients who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Patients with non-OSA sleep disorders.
- Patients in whom PAP therapy is otherwise medically contraindicated.
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC Sleep Disorder Program and Sleep Lab, UBC Hospital
Vancouver, British Columbia
About this study
Official title: A Randomized Cross Over Study to Compare REMStar Auto With C-Flex to Standard CPAP Therapy in Patients With OSAHS, and to Assess Its Safety, Tolerability and Efficacy and Preference Over CPAP.
This study will evaluate the use of REMStar Auto with C-Flex (RSA C-Flex) therapy in subjects with previously diagnosed obstructive sleep apnea / hypopnea syndrome, during in-laboratory studies. The study will determine the ability of RSA C-Flex therapy to effectively treat the sleep apnea events. Mask leak and key sleep parameters will be monitored, and are expected to be improved with C-Flex vs. CPAP therapy. Satisfaction from both patient and technician will also be monitored.
Read the detailed description
The research question we are exploring is whether the To determine if treatment with C-FLEX is at least equivalent to conventional CPAP therapy as evidenced by standard sleep and breathing variables and To determine if the treatment with C-FLEX has a positive impact as determined by patient and technologist assessment of the PSG experience.
Sleep laboratory rooms will be configured with a RSA device, which can deliver either conventional CPAP or Auto CPAP with C-Flex. Each night the subjects eligible for the trial will be interviewed, and consented for the study. The subjects will be instrumented for polysomnography and PAP titration (with PSG recording of RSA flow, estimated tidal volume, pressure, and estimated leak - via the Analog Output Module). Each subject will be instructed in PAP therapy (using standard methods), and have an appropriate patient interface selected per standard laboratory protocol. Each night, the patients will be randomized to either therapy (conventional CPAP therapy without C-Flex, or RSA C-Flex). PSG will be schedules to take place on consecutive nights when possible. The patient will not be aware of the therapy they will be subjected to, but the night technician will be aware of the therapy choice. On the next night, the subject will receive the alternative therapy (cross-over).
Conventional CPAP without C-Flex CPAP pressure will be set to the therapy pressure determined during a previous titration study. Technicians will record all interactions with the subject, as well as any equipment used in the study. Study data will be analyzed for standard polysomnographic outcome parameters listed below. Patient will complete a visual analog satisfaction questionnaire following the study.
RSA with C-Flex RSA C-Flex will be set with pressure range from 4 to 20 cmH2O. Patients will be arbitrarily set to a C-Flex comfort setting of 3 (maximum pressure relief). If the patient comments about any sensation of 'breathlessness' due to the pressure relief, comfort setting may be adjusted to 2 or 1 by the night technician. The subject is not informed of the therapy selected for the study. Technicians will record all interactions with the subject, as well as any equipment used in the study. Study data will be analyzed for standard polysomnographic outcome parameters listed below. Patient will complete a visual analog satisfaction questionnaire following the study.
Demographic Data: Age, gender composition, body mass index, and baseline (diagnostic) AHI will be presented with descriptive statistics. Appropriate statistical analysis will be performed to compare the results of the titration night with REMStar Auto to the night on conventional CPAP. Laboratory Experience: Number of interactions, types of interactions, equipment used and VAS of both patient and technician will be recorded for each subject. Polysomnographic Data, Cardiopulmonary and the process data will be collected and analyzed.
- Being tested
- REMStar Auto with C-Flex
- Keywords
- OSAHS and REMStar Auto with C-Flex
- 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.
REMStar Auto with C-FlexDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will compare apnea-hypopnea index (AHI) and standard sleep and breathing variables while on nasal CPAP vs REMStar Auto with C-Flex. Subject himself acts his own control
Secondary outcomes (3)
The study will also compare Polysomnographic Data.
This study will compare Cardiopulmonary
This study will compare Technician interactions with subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startFeb 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea Hypopnoea SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Najib Ayas, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358800
- Sponsor's protocol ID
- C04-0474
- Status last verified
- Jul 2006
- First submitted
- 28 Jul 2006
- Last updated
- 1 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross Over Study to Compare REMStar Auto With C-Flex to Standard CPAP Therapy in Patients With OSAHS, and to Assess Its Safety, Tolerability and Efficacy and Preference Over CPAP.
- ClinicalTrials.gov ID
- NCT00358800
- Acronym / sponsor ID
- C04-0474
- Keywords
- OSAHS and REMStar Auto with C-Flex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Dec 2005
- First posted
- 1 Aug 2006 (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.
This study will evaluate the use of REMStar Auto with C-Flex (RSA C-Flex) therapy in subjects with previously diagnosed obstructive sleep apnea / hypopnea syndrome, during in-laboratory studies. The study will determine the ability of RSA C-Flex therapy to effectively treat the sleep apnea events. Mask leak and key sleep parameters will be monitored, and are expected to be improved with C-Flex vs. CPAP therapy. Satisfaction from both patient and technician will also be monitored.
Detailed description
The research question we are exploring is whether the To determine if treatment with C-FLEX is at least equivalent to conventional CPAP therapy as evidenced by standard sleep and breathing variables and To determine if the treatment with C-FLEX has a positive impact as determined by patient and technologist assessment of the PSG experience.
Sleep laboratory rooms will be configured with a RSA device, which can deliver either conventional CPAP or Auto CPAP with C-Flex. Each night the subjects eligible for the trial will be interviewed, and consented for the study. The subjects will be instrumented for polysomnography and PAP titration (with PSG recording of RSA flow, estimated tidal volume, pressure, and estimated leak - via the Analog Output Module). Each subject will be instructed in PAP therapy (using standard methods), and have an appropriate patient interface selected per standard laboratory protocol. Each night, the patients will be randomized to either therapy (conventional CPAP therapy without C-Flex, or RSA C-Flex). PSG will be schedules to take place on consecutive nights when possible. The patient will not be aware of the therapy they will be subjected to, but the night technician will be aware of the therapy choice. On the next night, the subject will receive the alternative therapy (cross-over).
Conventional CPAP without C-Flex CPAP pressure will be set to the therapy pressure determined during a previous titration study. Technicians will record all interactions with the subject, as well as any equipment used in the study. Study data will be analyzed for standard polysomnographic outcome parameters listed below. Patient will complete a visual analog satisfaction questionnaire following the study.
RSA with C-Flex RSA C-Flex will be set with pressure range from 4 to 20 cmH2O. Patients will be arbitrarily set to a C-Flex comfort setting of 3 (maximum pressure relief). If the patient comments about any sensation of 'breathlessness' due to the pressure relief, comfort setting may be adjusted to 2 or 1 by the night technician. The subject is not informed of the therapy selected for the study. Technicians will record all interactions with the subject, as well as any equipment used in the study. Study data will be analyzed for standard polysomnographic outcome parameters listed below. Patient will complete a visual analog satisfaction questionnaire following the study.
Demographic Data: Age, gender composition, body mass index, and baseline (diagnostic) AHI will be presented with descriptive statistics. Appropriate statistical analysis will be performed to compare the results of the titration night with REMStar Auto to the night on conventional CPAP. Laboratory Experience: Number of interactions, types of interactions, equipment used and VAS of both patient and technician will be recorded for each subject. Polysomnographic Data, Cardiopulmonary and the process data will be collected and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Primary medical diagnosis Obstructive Sleep Apnea / Hypopnea Syndrome
- AHI ≥ 15 events•hr-1 of sleep
- Ability to provide consent
- Successful completion of a conventional CPAP titration in a sleep laboratory under polysomnographic conditions (success defined by reduction of AHI to < 5•hr-1 during therapeutic portion of study, in supine position and in REM and NREM sleep state).
Key exclusion criteria (6 listed)
- Patients who are medically complicated or who are medically unstable.
- Patients who have been on chronic CPAP or BiPAP therapy or require oxygen therapy.
- Patients with respiratory failure or respiratory insufficiency or who have elevated arterial carbon dioxide levels while awake.
- Patients who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Patients with non-OSA sleep disorders.
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 |
|---|---|---|
| REMStar Auto with C-Flex | Device | – |
Primary outcome
This study will compare apnea-hypopnea index (AHI) and standard sleep and breathing variables while on nasal CPAP vs REMStar Auto with C-Flex. Subject himself acts his own control
3 secondary outcomes
The study will also compare Polysomnographic Data.
This study will compare Cardiopulmonary
This study will compare Technician interactions with subject
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 1 Aug 2006.
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.
Najib Ayas principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMStar Auto with C-Flex in people with Obstructive Sleep Apnoea Hypopnoea Syndrome, run by University of British Columbia at 1 site in Canada.
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 6 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 1 Aug 2006. 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 Canada. 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?
This study will compare apnea-hypopnea index (AHI) and standard sleep and breathing variables while on nasal CPAP vs REMStar Auto with C-Flex. Subject himself acts his own control. 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 1 Aug 2006; AzTrials last refreshed its copy on 26 Oct 2026.