Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

April 10, 2018 updated by: L.B.L. Benoist, Onze Lieve Vrouwe Gasthuis

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • Antwerp University Hospital (UZA)
        • Contact:
          • O.M. Vanderveken, Professor
  • Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Combination therapy

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.
Device: Sleep position trainer
Device: Mandibular advancement device
Other Names:
  • MRA, MAD
ACTIVE_COMPARATOR: CPAPContinuous 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.
Device: Continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnea-hypopnea index (AHI)
Time Frame: change from baseline, after 3, 6 and 12 months
change from baseline, after 3, 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouwe Gasthuis

Collaborators

University Hospital, Antwerp

Investigators

  • Principal Investigator: O.M. Vanderveken, Professor, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (ESTIMATE)

September 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL52032.029.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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