OSAS (Obstructive Sleep Apneas Syndrome)Phase 3NCT00646477
ISIS 1 Therapeutic Effectiveness
A Phase 3 study testing titration night in people with OSAS (Obstructive Sleep Apneas Syndrome), run by Tyco Healthcare Group at 1 site in France.
Trial summary
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients. Precisely, the study was designed to : evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- OSAS (Obstructive Sleep Apneas Syndrome)
- What is being tested?
- titration night
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to May 2008
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient male or female, aged 18 to 75 years
- weight > 30kg
- patient with a newly diagnosed OSAS, under treatment with CPAP
- patient in stable condition
- patient affiliated to a social security insurance
- having given its written informed consent to participate to the study
Who cannot join
- pneumothorax or pneumomediastin history
- massive epistaxis (current or previous)
- decompensated heart failure or hypotension
- pneumoencephal history, recent trauma or surgery sequel with cranio-nasopharyngeal fistula
- acute sinusitis history, middle ear infection or perforation of the tympanic membrane
- respiratory insufficiency or severe respiratory illness with the possibility of residual hypoxemia
- severe bullous emphysema or previously complicated pneumothorax
- severe claustrophobia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospital Michalon, sleep disorders center
Grenoble, 38049
Jean-Louis PEPIN, Pr, +33 4 76 76 55 16, JLPepin@chu-grenoble.fr
Patrick Levy, Pr
About this study
Official title: Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.
Precisely, the study was designed to :
- evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
- determine the sensitivity and specificity of the device in adequately detecting respiratroy events
- compare effective pressure Peff determined by the device and during manual titration
- compare the impact of the two-speed descent pressure algorithm
Read the detailed description
During the study, each patient underwent one night of full polysomnography with two consecutives therapeutic sequences during the same night, after randomization of the passage order:
- autotitrating pressure phase: sleep parameters and respiratory events vs results of the polysomnographic registration,
- manual titration phase: concordance between events respiratory analyzed on the polysomnographic recordings and the events detected by the CPAP / auto-CPAP.
- Conditions
- OSAS (Obstructive Sleep Apneas Syndrome)
- Being tested
- titration night
- 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.
titration nightDevice
Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes:
in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes.
in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Phase 1 : manual Phase 2 : automatic Descent rate pressure : slow Receives: Device: titration night |
| B | Experimental | Phase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast Receives: Device: titration night |
| C | Experimental | Phase 1 : automatic Phase 2 : manual Descent rate pressure : slow Receives: Device: titration night |
| D | Experimental | Phase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast Receives: Device: titration night |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitivity and specificity of the CPAP/autoCPAP Sandman in adequately detecting respiratory events and to evaluate the therapeutic effectiveness of the device in improving sleep quality and normalizing respiratory events
Measured: May 2008
Secondary outcomes (2)
To compare effective pressure Peff determined by the device and during manual titration
Measured: May 2008
To compare the impact of the two-speed descent pressure algorithm
Measured: May 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2008 (estimated)
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAS (Obstructive Sleep Apneas Syndrome)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyco Healthcare Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Veronique Grillier-Lanoir, Study chair, Tyco Healthcare Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646477
- Sponsor's protocol ID
- ISIS 1
- Status last verified
- Mar 2008
- First submitted
- 25 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome
- ClinicalTrials.gov ID
- NCT00646477
- Acronym / sponsor ID
- ISIS 1
- Conditions
- OSAS (Obstructive Sleep Apneas Syndrome)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tyco Healthcare GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2008 (estimated)
- First posted
- 28 Mar 2008 (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.
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.
Precisely, the study was designed to :
- evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
- determine the sensitivity and specificity of the device in adequately detecting respiratroy events
- compare effective pressure Peff determined by the device and during manual titration
- compare the impact of the two-speed descent pressure algorithm
Detailed description
During the study, each patient underwent one night of full polysomnography with two consecutives therapeutic sequences during the same night, after randomization of the passage order:
- autotitrating pressure phase: sleep parameters and respiratory events vs results of the polysomnographic registration,
- manual titration phase: concordance between events respiratory analyzed on the polysomnographic recordings and the events detected by the CPAP / auto-CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: titration nightPhase 1 : manual Phase 2 : automatic Descent rate pressure : slow |
| B | Experimental | Device: titration nightPhase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast |
| C | Experimental | Device: titration nightPhase 1 : automatic Phase 2 : manual Descent rate pressure : slow |
| D | Experimental | Device: titration nightPhase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient male or female, aged 18 to 75 years
- weight > 30kg
- patient with a newly diagnosed OSAS, under treatment with CPAP
- patient in stable condition
- patient affiliated to a social security insurance
Key exclusion criteria (8 listed)
- pneumothorax or pneumomediastin history
- massive epistaxis (current or previous)
- decompensated heart failure or hypotension
- pneumoencephal history, recent trauma or surgery sequel with cranio-nasopharyngeal fistula
- acute sinusitis history, middle ear infection or perforation of the tympanic membrane
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 |
|---|---|---|
| titration nightEach subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes: in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes. in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events. | Device | A, B, C, D |
Primary outcome
To determine the sensitivity and specificity of the CPAP/autoCPAP Sandman in adequately detecting respiratory events and to evaluate the therapeutic effectiveness of the device in improving sleep quality and normalizing respiratory events
Time frame: May 2008
2 secondary outcomes
To compare effective pressure Peff determined by the device and during manual titration
Time frame: May 2008
To compare the impact of the two-speed descent pressure algorithm
Time frame: May 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2008.
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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.
Veronique Grillier-Lanoir study chair
Tyco Healthcare Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing titration night in people with OSAS (Obstructive Sleep Apneas Syndrome), run by Tyco Healthcare Group at 1 site in France.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Mar 2008. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the sensitivity and specificity of the CPAP/autoCPAP Sandman in adequately detecting respiratory events and to evaluate the therapeutic effectiveness of the device in improving sleep quality and normalizing respiratory events (time frame: May 2008). 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 28 Mar 2008.