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

NCT05268471 | Unknown FDA Device

• 1 other identifier: PAVLOV
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  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.

  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

  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.

  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

  1 month

Study Arms (2)

Positional Device (PD)

EXPERIMENTAL

Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea

Device: Positional device (PD)

Continuos Positive Airway Pressure (CPAP)

ACTIVE COMPARATOR

Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea

Device: Continuos Positive Airway Pressure (CPAP)

Interventions

Positional device (PD) DEVICE

OSA treatment with PD for 6 months

Positional Device (PD)

Continuos Positive Airway Pressure (CPAP) DEVICE

OSA treatment with CPAP for 6 months

Continuos Positive Airway Pressure (CPAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead
• Philips Healthcare: collaborator

Study Sites (1)

Hospital Universitario Ramón y Cajal, Pneumology Department

Madrid, 28034, Spain

Location

Study Officials

• Irene Cano-Pumarega, MD, PhD

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Cano-Pumarega

CONTACT

+34686348243; irene.cano@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sleep Unit Coordinator, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 7, 2022
• Study Start: October 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 1, 2024
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)