Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

Not Applicable

• Conditions: Positional Obstructive Sleep Apnea
• Interventions: Device: Continuous positive airway pressure; Device: Sleep position trainer; Device: Mandibular advancement device

• Registration Number: NCT02553902
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 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.)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAPContinuous positive airway pressure	Continuous 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.
Combination therapy	Mandibular advancement device	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.
Combination therapy	Sleep position trainer	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.

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index (AHI)	change from baseline, after 3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
(Societal) costs of treatment	change from baseline, after 3, 6 and 12 months	iMTA Medical Consumption Questionnaire (iMCQ)
Outcome of Quality of Life questionnaires	change from baseline, after 3, 6 and 12 months	Functional Outcome Sleep Questionnaire (FOSQ)
Therapy compliance	change from baseline, after 3, 6 and 12 months	Measurement of actual wearing time (in hours) per night
Cardiovascular parameters	change from baseline, after 3, 6 and 12 months	Pulse rate

Trial Locations

Locations (2)

OLVG West; 🇳🇱 Amsterdam, Netherlands

Antwerp University Hospital (UZA); 🇧🇪 Antwerp, Belgium