Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
NCT ID: NCT02553902
Last Updated: 2018-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2015-09-30
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).
HYPOTHESIS:
The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.
STUDY DESIGN:
A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.
STUDY POPULATION:
Patients diagnosed with moderate POSA according to polysomnography (PSG) results.
INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:
The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.
OUTCOME MEASURES:
AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)
SAMPLE SIZE / DATA ANALYSIS:
100 subjects in each treatment group, total of 200 patients.
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:
The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy
NCT01535521
First Line Obstructive Sleep Apnea Treatment Study
NCT05393531
Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
NCT01666886
RCT: Oral Appliance Therapy and Sleep Position Trainer in Patients With Position Dependant Obstructive Sleep Apnea
NCT02045576
Clinial Study of Treatment With Mandibular Advancement Device in Patients With Obstructive Sleep Apnea Across 6 General Hospitals
NCT06837285
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Combination therapy
Sleep Position Trainer + Mandibular Advancement device combination The SPT is a sensor that measures the sleeping position, and gives the user feedback about wrong positions with a soft vibration. A user is then able to react to the signal and turn into a non-supine position. To stimulate compliance, information is provided about nightly behaviour, implicating a learning pattern by viewing the data on a home computer.
MRA or oral appliances (OA) works by advancing the mandible and its attached soft tissue structures forward they aim to increase upper airway size.
Sleep position trainer
Mandibular advancement device
CPAPContinuous positive airway pressure
Continuous positive airway pressure (CPAP) functions as a pneumatic splint to maintain upper airway patency. Possible side effect can be related to the interface, pressure and negative social factors.
Continuous positive airway pressure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sleep position trainer
Mandibular advancement device
Continuous positive airway pressure
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to speak, read and write Dutch
* Ability to follow up
* Diagnosis with symptomatic moderate OSA (15 \< AHI \< 30)
* Diagnosis of 10 to 90% supine position during the night
* AHI supine is 2 \> as high as AHI non-supine
* Own a Windows PC and ability to install SPT connection software and upload research data
* Expected to maintain current lifestyle (sports, medicine, diet etc.)
Exclusion Criteria
* Medication used/ related to sleeping disorders
* Central Sleep Apnea Syndrome
* Night or shifting work
* Severe chronic heart failure
* Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy)
* Seizure disorder
* Known medical history of mental retardation, memory disorders or psychiatric disorders
* Shoulder, neck and back complaints
* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils)
* Inability to provide informed consent
* Simultaneous use of other treatment modalities to treat OSA
* Previous treatment for OSA with MRA, CPAP or SPT
* Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Antwerp
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
L.B.L. Benoist
Drs.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
O.M. Vanderveken, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Antwerp University Hospital (UZA)
Antwerp, , Belgium
OLVG West
Amsterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
O.M. Vanderveken, Professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL52032.029.15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.