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

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

Cost-effectiveness Analysis and Conditional Response to the Effect of Active Postural Devices in Postural Obstructive Sleep Apnea. Pávlov Project.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05268471
• Other study ID #: PAVLOV
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2022
• Source: Hospital Universitario Ramon y Cajal
• Contact: Irene Cano-Pumarega
• Phone: +34686348243
• Email: irene.cano[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: December 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Positional device (PD)
OSA treatment with PD for 6 months
• Continuos Positive Airway Pressure (CPAP)
OSA treatment with CPAP for 6 months

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal, Pneumology Department	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal	Philips Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account: AIH (measured by RP)	6 months
Secondary	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.	To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account the degree of daytime sleepiness, measured by the Epworth scale (0-24, where higher scores mean a worse outcome)	6 months
Secondary	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	To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account the quality-adjusted life years, measured by the European Quality of Life 5 dimensions (EuroQol-5D) questionnaire (5 dimensions from 1 to 3 points in each one, where higher scores mean a worse outcome)	6 months
Secondary	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.	To assess the cost-effectiveness of NightBalance PD in the treatment of OSA compared to CPAP treatment after 6 months of treatment and assessed by the difference in cost between the two treatment methods divided by the difference in effectiveness between the two treatment methods taking into account health resources consumed in euros: Initial cost of the device, maintenance costs (consumables, revisions), hospital costs (hospital visits for training, troubleshooting, pressure titration, parameter adjustment, follow-up visits), patient costs (device, consumables, travel).	6 months
Secondary	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	Apnea hypopnea index (AHI) measured by respiratory polygraphy (RP) after 1 week and 1 month of withdrawing active treatment will be assesed and compared to AHI after active treatment with NightBalance for 6 months.	1 month