Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

Onze Lieve Vrouwe Gasthuis

Status: Unknown

Conditions: Positional Obstructive Sleep Apnea

Treatments: Device: Continuous positive airway pressure; Device: Sleep position trainer; Device: Mandibular advancement device

Study type: Interventional

Funder types: Other

Identifiers

NCT02553902

NL52032.029.15

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Combination therapy

Active Comparator group

Description:

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.

Treatment:

Device: Mandibular advancement device

Device: Sleep position trainer

CPAPContinuous positive airway pressure

Active Comparator group

Description:

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.

Treatment:

Device: Continuous positive airway pressure