Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
1 other identifier
interventional
200
2 countries
2
Brief Summary
OBJECTIVES: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 14, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 11, 2018
April 1, 2018
3.3 years
September 14, 2015
April 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea-hypopnea index (AHI)
change from baseline, after 3, 6 and 12 months
Secondary Outcomes (8)
Outcome of Quality of Life questionnaires
change from baseline, after 3, 6 and 12 months
Outcome of Quality of Life questionnaires
change from baseline, after 3, 6 and 12 months
Outcome of Quality of Life questionnaires
change from baseline, after 3, 6 and 12 months
(Societal) costs of treatment
change from baseline, after 3, 6 and 12 months
(Societal) costs of treatment
change from baseline, after 3, 6 and 12 months
- +3 more secondary outcomes
Study Arms (2)
Combination therapy
ACTIVE COMPARATORSleep 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.
CPAPContinuous positive airway pressure
ACTIVE COMPARATORContinuous 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.
Interventions
Eligibility Criteria
You may qualify if:
- years and older
- 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.)
You may not qualify if:
- Many dental problems; insufficient teeth for wearing MRA
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Onze Lieve Vrouwe Gasthuislead
- University Hospital, Antwerpcollaborator
Study Sites (2)
Antwerp University Hospital (UZA)
Antwerp, Belgium
OLVG West
Amsterdam, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
O.M. Vanderveken, Professor
University Hospital, Antwerp
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Drs.
Study Record Dates
First Submitted
September 14, 2015
First Posted
September 18, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
April 11, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share