Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Helios Klinik Ambrock | OTHER |
Not provided
Not provided
Not provided
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.
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
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;
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | 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: |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy to treat OSA | Nights 3, 4 and 5 (after each PSG) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Nights 3, 4 and 5 (after each PSG) | |
| Participant Treatment Preference: HF-CPAP compared with CPAP | Night 5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Nilius, M.D | HELIOS-Klinik Hagen Ambrock | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HELIOS-Klinik Hagen Ambrock | Ambrocker Weg 60 | Hagen | D 58091 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
Not provided
Not provided