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.

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.

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.