Back to resultsCost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea of Adult
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Positional device (PD)
Continuos Positive Airway Pressure (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea of Adult
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years of age.
- Signed informed consent.
Diagnosis of POSA by respiratory polygraphy with the following criteria:
- AHI ≥ 15/h or AHI ≥ 10/h and AHI <15/h with an Epworth >10
- AHI ns <10/h (<5/h in mild OSA).
- AHI is at least twice the AHI in ns
- Time in supine >20%.
- Valid recording time>4h
Exclusion Criteria:
- Treatment of OSA with CPAP or DAM in the previous month or treatment with surgery for OSA at any time.
- Presence of other sleep disorders or central sleep apnea (central AHI >50% of total AHI).
- Severe cardiovascular, neuromuscular or pulmonary pathology or chronic home oxygen use.
- Poorly controlled arterial hypertension or refractory arterial hypertension.
- Condition that makes it difficult or impossible to change position during sleep.
- Epworth scale score ≥ 16.
- Professional driver, heavy machinery operator or shift worker.
- Pregnancy.
- Treatment with medication that may interfere with alertness or drowsiness such as: sedative antidepressants, hypnotics, opioids, anticonvulsants or central nervous system stimulants.
Sites / Locations
- Hospital Universitario Ramón y Cajal, Pneumology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Positional Device (PD)
Continuos Positive Airway Pressure (CPAP)
Arm Description
Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea
Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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)
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)
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).
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.
Full Information
NCT ID
NCT05268471
First Posted
February 8, 2022
Last Updated
August 22, 2022
Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Philips Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT05268471
Brief Title
Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea
Official Title
Cost-effectiveness Analysis and Conditional Response to the Effect of Active Postural Devices in Postural Obstructive Sleep Apnea. Pávlov Project.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Philips Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The objectives of this study are:
To assess the effectiveness and cost-effectiveness of a vibrating positional device (NightBalance, Philips) in the treatment of positional obstructive sleep apnea compared to conventional CPAP treatment.
To investigate whether a positional device (NightBalance, Philips) avoids supine position after a period of use of the device without actively using the device for a subsequent period of time.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positional Device (PD)
Arm Type
Experimental
Arm Description
Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea
Arm Title
Continuos Positive Airway Pressure (CPAP)
Arm Type
Active Comparator
Arm Description
Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea
Intervention Type
Device
Intervention Name(s)
Positional device (PD)
Intervention Description
OSA treatment with PD for 6 months
Intervention Type
Device
Intervention Name(s)
Continuos Positive Airway Pressure (CPAP)
Intervention Description
OSA treatment with CPAP for 6 months
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
6 months
Title
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.
Description
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)
Time Frame
6 months
Title
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
Description
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)
Time Frame
6 months
Title
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.
Description
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).
Time Frame
6 months
Title
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
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years of age.
Signed informed consent.
Diagnosis of POSA by respiratory polygraphy with the following criteria:
AHI ≥ 15/h or AHI ≥ 10/h and AHI <15/h with an Epworth >10
AHI ns <10/h (<5/h in mild OSA).
AHI is at least twice the AHI in ns
Time in supine >20%.
Valid recording time>4h
Exclusion Criteria:
Treatment of OSA with CPAP or DAM in the previous month or treatment with surgery for OSA at any time.
Presence of other sleep disorders or central sleep apnea (central AHI >50% of total AHI).
Severe cardiovascular, neuromuscular or pulmonary pathology or chronic home oxygen use.
Poorly controlled arterial hypertension or refractory arterial hypertension.
Condition that makes it difficult or impossible to change position during sleep.
Epworth scale score ≥ 16.
Professional driver, heavy machinery operator or shift worker.
Pregnancy.
Treatment with medication that may interfere with alertness or drowsiness such as: sedative antidepressants, hypnotics, opioids, anticonvulsants or central nervous system stimulants.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Cano-Pumarega
Phone
+34686348243
Email
irene.cano@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Cano-Pumarega, MD, PhD
Organizational Affiliation
Hospital Universitario Ramón y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Ramón y Cajal, Pneumology Department
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea
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