Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

Positional Obstructive Sleep Apnea Clinical Trial

Official title:

Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02553902
• Other study ID #: NL52032.029.15
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2015
• Last updated: April 10, 2018
• Start date: September 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: Patty Vonk, MD
• Email: researchkno[@]olvg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Positional Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Sleep position trainer

• Mandibular advancement device

• Continuous positive airway pressure

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital (UZA)	Antwerp
Netherlands	OLVG West	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis	University Hospital, Antwerp

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index (AHI)		change from baseline, after 3, 6 and 12 months
Secondary	Outcome of Quality of Life questionnaires	EQ-5D	change from baseline, after 3, 6 and 12 months
Secondary	Outcome of Quality of Life questionnaires	Epworth Sleeping Scale (ESS)	change from baseline, after 3, 6 and 12 months
Secondary	Outcome of Quality of Life questionnaires	Functional Outcome Sleep Questionnaire (FOSQ)	change from baseline, after 3, 6 and 12 months
Secondary	(Societal) costs of treatment	iMTA Productivity Cost Questionnaire (iPCQ)	change from baseline, after 3, 6 and 12 months
Secondary	(Societal) costs of treatment	iMTA Medical Consumption Questionnaire (iMCQ)	change from baseline, after 3, 6 and 12 months
Secondary	Therapy compliance	Measurement of actual wearing time (in hours) per night	change from baseline, after 3, 6 and 12 months
Secondary	Cardiovascular parameters	Systolic and diastolic blood pressure	change from baseline, after 3, 6 and 12 months
Secondary	Cardiovascular parameters	Pulse rate	change from baseline, after 3, 6 and 12 months