Clinical trial NCT02553902: Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
Official title: Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Positional Obstructive Sleep Apnea
Keywords: Positional therapy
MAD
Oral appliance
Sleep position trainer
POSA
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2015-09-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: change from baseline, after 3, 6 and 12 months
Secondary outcomes:
measure: Outcome of Quality of Life questionnaires
timeFrame: change from baseline, after 3, 6 and 12 months
measure: Outcome of Quality of Life questionnaires
timeFrame: change from baseline, after 3, 6 and 12 months
measure: Outcome of Quality of Life questionnaires
timeFrame: change from baseline, after 3, 6 and 12 months
measure: (Societal) costs of treatment
timeFrame: change from baseline, after 3, 6 and 12 months
measure: (Societal) costs of treatment
timeFrame: change from baseline, after 3, 6 and 12 months
measure: Therapy compliance
timeFrame: change from baseline, after 3, 6 and 12 months
measure: Cardiovascular parameters
timeFrame: change from baseline, after 3, 6 and 12 months
measure: Cardiovascular parameters
timeFrame: change from baseline, after 3, 6 and 12 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital (UZA)
city: Amsterdam
country: Netherlands
facility: OLVG West
Study officials:
affiliation: University Hospital, Antwerp
name: O.M. Vanderveken, Professor
role: PRINCIPAL_INVESTIGATOR
References: