Clinical trial NCT05268471: Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea
Official title: Cost-effectiveness Analysis and Conditional Response to the Effect of Active Postural Devices in Postural Obstructive Sleep Apnea. Pávlov Project.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2022-03-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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)
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: 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
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal, Pneumology Department
Study officials:
affiliation: Hospital Universitario Ramón y Cajal
name: Irene Cano-Pumarega, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: