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

Madrid Health Service

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Device: Positional device (PD); Device: Continuos Positive Airway Pressure (CPAP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05268471

PAVLOV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Positional Device (PD)

Experimental group

Description:

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

Treatment:

Device: Positional device (PD)

Continuos Positive Airway Pressure (CPAP)

Active Comparator group

Description:

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

Treatment:

Device: Continuos Positive Airway Pressure (CPAP)