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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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The objectives of this study are:
Non-inferiority clinical trial open to patients and investigators, multicenter, randomized and controlled to treatment with positional device (PD) and CPAP to evaluate the effectiveness of treatment of positional obstructive sleep apnea with a PD (NightBalance, Philips) compared to CPAP after 6 months of continuous treatment (first phase) and the permanence of such efficacy after subsequent discontinuation of treatment (second phase).
An initial respiratory polygraphy will be performed in all patients and the sleep study will be repeated at 6 months with PD and CPAP. After its withdrawal, in those patients who respond, the respiratory polygraphy will be repeated at one week and one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positional Device (PD) | Experimental | Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea |
|
| Continuos Positive Airway Pressure (CPAP) | Active Comparator | Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positional device (PD) | Device | OSA treatment with PD for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of a positional device (PD) (NightBalance, Philips) compared to continuous positive airway pressure (CPAP) in the treatment of OSA assessed by the intergroup differences in apnea hypopnea index (AHI) measured by respiratory polygraphy (RP) | To evaluate the effectiveness of a positional device (PD) (NightBalance, Philips) compared to continuous positive airway pressure (CPAP) in the treatment of OSA by assessing the apnea hypopnea index (AHI) measured by respiratory polygraphy (RP) after 6 months of treatment in a non-inferiority analysis. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account the AIH measured by RP. | To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account: AIH (measured by RP) |
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Inclusion Criteria:
Patients over 18 years of age.
Signed informed consent.
Diagnosis of POSA by respiratory polygraphy with the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Cano-Pumarega | Contact | +34686348243 | irene.cano@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Irene Cano-Pumarega, MD, PhD | Hospital Universitario Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal, Pneumology Department | Madrid | 28034 | Spain |
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| Continuos Positive Airway Pressure (CPAP) |
| Device |
OSA treatment with CPAP for 6 months |
|
| 6 months |
| Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account the degree of daytime sleepiness measured by the Epworth scale. | To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account the degree of daytime sleepiness, measured by the Epworth scale (0-24, where higher scores mean a worse outcome) | 6 months |
| Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account the quality-adjusted life years measured by the EuroQol-5D questionnaire | To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account the quality-adjusted life years, measured by the European Quality of Life 5 dimensions (EuroQol-5D) questionnaire (5 dimensions from 1 to 3 points in each one, where higher scores mean a worse outcome) | 6 months |
| Cost-effectiveness of PD in the treatment of OSA compared to CPAP and assessed by the difference in cost between both devices taking into account health resources consumed. | To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account health resources consumed in euros: Initial cost of the device, maintenance costs (consumables, revisions), hospital costs (hospital visits for training, troubleshooting, pressure titration, parameter adjustment, follow-up visits), patient costs (device, consumables, travel). | 6 months |
| Conditioned response of PD assesed by the apnea hypopnea index (AHI) measured by respiratory polygraphy (RP) after 1 week and 1 month of withdrawing active treatment | Apnea hypopnea index (AHI) measured by respiratory polygraphy (RP) after 1 week and 1 month of withdrawing active treatment will be assesed and compared to AHI after active treatment with NightBalance for 6 months. | 1 month |