Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea

Cost-effectiveness Analysis and Conditional Response to the Effect of Active Postural Devices in Postural Obstructive Sleep Apnea. Pávlov Project.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Device: Positional device (PD); Device: Continuos Positive Airway Pressure (CPAP)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Cano-Pumarega; Phone Number: +34686348243; Email: irene.cano@yahoo.com

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal, Pneumology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positional Device (PD); Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea	Device: Positional device (PD); OSA treatment with PD for 6 months
Active Comparator: Continuos Positive Airway Pressure (CPAP); Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea	Device: Continuos Positive Airway Pressure (CPAP); OSA treatment with CPAP for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Irene Cano-Pumarega, MD, PhD, Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PAVLOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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