Obstructive Sleep ApneaNCT01025440
An Investigation to Test the Efficacy of the High Flow (HF) Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea (OSA)
A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Germany.
Trial summary
Phase One: High Flow (HF) CPAP (HF-CPAP) Titration: Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first half of the night and swapped to the alternate flow rate for the second half o the… 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?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to May 2010
- 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
- Aged ≥ 18 years.
- AHI > 15 events per hour and ≥ 90% of events must be Hypopneas.
Who cannot join
- Any medical condition which contraindicates the use of CPAP or AutoCPAP. See Appendix D for this list.
- Requires supplemental oxygen.
- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- Unstable psychiatric disease.
- Other significant sleep disorder.
- Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined by the investigation investigator.
- Any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements.
- Participation in another clinical investigation in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation to Test the Efficacy of a Novel CPAP Concept to Reduce the Apnea Hypopnea Index of Patients With Obstructive Sleep Apnea
Phase One:
High Flow (HF) CPAP (HF-CPAP) Titration:
Read more
Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first half of the night and swapped to the alternate flow rate for the second half o the night.
At the completion of night 3 participants will be categorized as responders or non-responders. Only responders will continue to Phase 2 of the investigation.
Phase Two:
HF-CPAP compared with CPAP:
Participants will attend the sleep lab to undergo a comprehensive overnight respiratory PSG. Each participant will be randomized to HF-CPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm. Thew following night participants will undergo the alternative treatment arm for the duration of the night.
Read the detailed description
Each patient will complete a clinical consultation followed by admission to the HELIOS Klinik Hagen-Ambrock facility to undergo routine assessment, diagnosis and CPAP titration (if necessary) of OSA. This will be performed according to the routine clinical care procedures and protocols of the site. The eligibility of each participant will be established during these routine clinical care nights. After night 2 eligible participants will be offered participation in the investigation.
Phase One:
Night 1 (Routine Clinical Care) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive overnight diagnostic PSG, in order to establish the existence and severity of OSA. If the participant has
- a positive diagnosis of OSA with an AHI > 15 events/hr and
- ≥ 90% of all events are Hypopneas they will be eligible to progress to Night 3. Night 2 (Routine Clinical Care) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a standard CPAP titration, in order to determine their therapeutic CPAP pressure. At this stage, if the participant is eligible, they will be offered participation in the investigation. If potential participants are ineligible or unwilling to participate, they will continue along the routine clinical care path.
Night 3 (Flow Titration) Consented participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive split-night respiratory PSG.
Each participant will be randomized to one of 20 L/min or 35 L/min of HF-CPAP for the first half of the night. A minimum of three hours on this flow must be recorded on the PSG before participants can be swapped to the alternate flow. Three hours on the alternate flow is also required for this half of the night to be deemed successful.
Responder/Non-responder Determination At the completion of night 3 participants will be categorized as responders or non-responders.
Only responders will continue to Phase 2 of the investigation. A responder is someone who;
- Achieves a > 50% reduction in AHI and
- Achieves an RDI < 10 events/hr. Investigation Break Before responders progress to Phase Two participants will be sent home for 1 week. During this time they will be instructed to undertake CPAP treatment. Their CPAP device will be set to their therapeutic pressure which was determined on Night 2.
Phase Two:
Night 4 (HF-CPAP compared with CPAP) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive overnight respiratory PSG.
Each participant will be randomized to OpenCPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm.
Night 5 (HF-CPAP compared with CPAP) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive overnight respiratory PSG.
Participants will be swapped to the alternative treatment arm, either HF-CPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment. In the morning at completion of the PSG, participants will be asked which treatment Night (4 or 5) they preferred.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure
- 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.
Continuous Positive Airway PressureDevice
Also called Positive airway pressure
Continuous Positive Airway Pressure (CPAP) Dose: A flow (35 L/min) or pressure (btw 4 and 20 cmH20 -individual to each subject) is set on the device.
Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)
Duration:
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA.
Dose: The CPAP pressure will be set to the individual subject's therapeutic pressure -as determined by PSG on Night 2.
Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required) Receives: Device: Continuous Positive Airway Pressure |
| HFCPAP | Active comparator | Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA.
Dose: During HF CPAP 35 L/min wil be administered.
Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required) Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy to treat OSA
Measured: Nights 3, 4 and 5 (after each PSG)
Secondary outcomes (2)
Sleep Quality
Measured: Nights 3, 4 and 5 (after each PSG)
Participant Treatment Preference: HF-CPAP compared with CPAP
Measured: Night 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMay 2010
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 Fisher and Paykel HealthcareThe 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
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helios Klinik Ambrock
- Responsible party
- Sponsor
- Investigators
- George Nilius, M.D, Principal investigator, HELIOS-Klinik Hagen Ambrock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025440
- Sponsor's protocol ID
- FPHC LP-CPAP09-01
- Status last verified
- Jun 2017
- First submitted
- 1 Dec 2009
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation to Test the Efficacy of a Novel CPAP Concept to Reduce the Apnea Hypopnea Index of Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01025440
- Acronym / sponsor ID
- FPHC LP-CPAP09-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Helios Klinik Ambrock
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Dec 2009 (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.
Phase One:
High Flow (HF) CPAP (HF-CPAP) Titration:
Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first half of the night and swapped to the alternate flow rate for the second half o the night.
At the completion of night 3 participants will be categorized as responders or non-responders. Only responders will continue to Phase 2 of the investigation.
Phase Two:
HF-CPAP compared with CPAP:
Participants will attend the sleep lab to undergo a comprehensive overnight respiratory PSG. Each participant will be randomized to HF-CPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm. Thew following night participants will undergo the alternative treatment arm for the duration of the night.
Detailed description
Each patient will complete a clinical consultation followed by admission to the HELIOS Klinik Hagen-Ambrock facility to undergo routine assessment, diagnosis and CPAP titration (if necessary) of OSA. This will be performed according to the routine clinical care procedures and protocols of the site. The eligibility of each participant will be established during these routine clinical care nights. After night 2 eligible participants will be offered participation in the investigation.
Phase One:
Night 1 (Routine Clinical Care) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive overnight diagnostic PSG, in order to establish the existence and severity of OSA. If the participant has
- a positive diagnosis of OSA with an AHI > 15 events/hr and
- ≥ 90% of all events are Hypopneas they will be eligible to progress to Night 3. Night 2 (Routine Clinical Care) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a standard CPAP titration, in order to determine their therapeutic CPAP pressure. At this stage, if the participant is eligible, they will be offered participation in the investigation. If potential participants are ineligible or unwilling to participate, they will continue along the routine clinical care path.
Night 3 (Flow Titration) Consented participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive split-night respiratory PSG.
Each participant will be randomized to one of 20 L/min or 35 L/min of HF-CPAP for the first half of the night. A minimum of three hours on this flow must be recorded on the PSG before participants can be swapped to the alternate flow. Three hours on the alternate flow is also required for this half of the night to be deemed successful.
Responder/Non-responder Determination At the completion of night 3 participants will be categorized as responders or non-responders.
Only responders will continue to Phase 2 of the investigation. A responder is someone who;
- Achieves a > 50% reduction in AHI and
- Achieves an RDI < 10 events/hr. Investigation Break Before responders progress to Phase Two participants will be sent home for 1 week. During this time they will be instructed to undertake CPAP treatment. Their CPAP device will be set to their therapeutic pressure which was determined on Night 2.
Phase Two:
Night 4 (HF-CPAP compared with CPAP) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive overnight respiratory PSG.
Each participant will be randomized to OpenCPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm.
Night 5 (HF-CPAP compared with CPAP) Participants will attend the HELIOS Klinik Hagen-Ambrock sleep lab to undergo a comprehensive overnight respiratory PSG.
Participants will be swapped to the alternative treatment arm, either HF-CPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment. In the morning at completion of the PSG, participants will be asked which treatment Night (4 or 5) they preferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Device: Continuous Positive Airway PressureContinuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA. Dose: The CPAP pressure will be set to the individual subject's therapeutic pressure -as determined by PSG on Night 2. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required) |
| HFCPAP | Active comparator | Device: Continuous Positive Airway PressureContinuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA. Dose: During HF CPAP 35 L/min wil be administered. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 18 years.
- AHI > 15 events per hour and ≥ 90% of events must be Hypopneas.
Key exclusion criteria (8 listed)
- Any medical condition which contraindicates the use of CPAP or AutoCPAP. See Appendix D for this list.
- Requires supplemental oxygen.
- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- Unstable psychiatric disease.
- Other significant sleep disorder.
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 |
|---|---|---|
| Continuous Positive Airway PressureAlso: Positive airway pressureContinuous Positive Airway Pressure (CPAP) Dose: A flow (35 L/min) or pressure (btw 4 and 20 cmH20 -individual to each subject) is set on the device. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required) Duration: | Device | CPAP, HFCPAP |
Primary outcome
Efficacy to treat OSA
Time frame: Nights 3, 4 and 5 (after each PSG)
2 secondary outcomes
Sleep Quality
Time frame: Nights 3, 4 and 5 (after each PSG)
Participant Treatment Preference: HF-CPAP compared with CPAP
Time frame: Night 5
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 19 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
George Nilius, M.D principal investigator
HELIOS-Klinik Hagen Ambrock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 19 Jun 2017. 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 Germany. 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?
Efficacy to treat OSA (time frame: Nights 3, 4 and 5 (after each PSG)). 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 19 Jun 2017.