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

NCT ID: NCT05268471

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-12-01

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.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positional Device (PD)

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

Group Type: EXPERIMENTAL

Positional device (PD)

Intervention Type: DEVICE

OSA treatment with PD for 6 months

Continuos Positive Airway Pressure (CPAP)

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

Group Type: ACTIVE_COMPARATOR

Continuos Positive Airway Pressure (CPAP)

Intervention Type: DEVICE

OSA treatment with CPAP for 6 months

Interventions

Positional device (PD)

OSA treatment with PD for 6 months

Intervention Type: DEVICE

Continuos Positive Airway Pressure (CPAP)

OSA treatment with CPAP for 6 months

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Irene Cano-Pumarega

Sleep Unit Coordinator, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene Cano-Pumarega, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Locations

Hospital Universitario Ramón y Cajal, Pneumology Department

Madrid, , Spain

Countries

Spain

Central Contacts

Irene Cano-Pumarega

Role: CONTACT

irene.cano@yahoo.com

+34686348243

Other Identifiers

PAVLOV

Identifier Type: -

Identifier Source: org_study_id