Obstructive Sleep Apnea of AdultNCT05268471
Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea
A study testing Positional device (PD) and Continuos Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea of Adult, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Positional device (PD) and Continuos Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Ramón y Cajal, Pneumology Department
Madrid, 28034
About this study
Official title: 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.
Read the 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
- Being tested
- Positional device (PD), Continuos Positive Airway Pressure (CPAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional device (PD)Device
OSA treatment with PD for 6 months
Continuos Positive Airway Pressure (CPAP)Device
OSA treatment with CPAP for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Positional Device (PD) | Experimental | Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea Receives: Device: Positional device (PD) |
| Continuos Positive Airway Pressure (CPAP) | Active comparator | Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea Receives: Device: Continuos Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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)
Measured: 6 months
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)
Measured: 6 months
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)
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Irene Cano-Pumarega, Hospital Universitario Ramon y Cajal
- Investigators
- Irene Cano-Pumarega, MD, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268471
- Sponsor's protocol ID
- PAVLOV
- Status last verified
- Aug 2022
- First submitted
- 8 Feb 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis and Conditional Response to the Effect of Active Postural Devices in Postural Obstructive Sleep Apnea. Pávlov Project.
- ClinicalTrials.gov ID
- NCT05268471
- Acronym / sponsor ID
- PAVLOV
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positional Device (PD) | Experimental | Device: Positional device (PD)Vibrating positional device (Nightbalance, Philips) to treat positional obstructive sleep apnea |
| Continuos Positive Airway Pressure (CPAP) | Active comparator | Device: Continuos Positive Airway Pressure (CPAP)Continuos Positive Airway Pressure (standard treatment) to treat obstructive sleep apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients over 18 years of age.
- Signed informed consent.
- Diagnosis of POSA by respiratory polygraphy with the following criteria:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positional device (PD)OSA treatment with PD for 6 months | Device | Positional Device (PD) |
| Continuos Positive Airway Pressure (CPAP)OSA treatment with CPAP for 6 months | Device | Continuos Positive Airway Pressure (CPAP) |
Primary outcome
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)
Time frame: 6 months
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.
5 secondary outcomes
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.
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea of Adult
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
RecruitingPhase 4
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
Obstructive Sleep Apnea (OSA)
Not yet recruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Cano-Pumarega, MD, PhD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positional device (PD) and Continuos Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea of Adult, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Cano-Pumarega (+34686348243, irene.cano@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.