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Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

This study is currently recruiting participants.
Verified June 2017 by L.B.L. Benoist, Onze Lieve Vrouwe Gasthuis
Sponsor:
ClinicalTrials.gov Identifier:
NCT02553902
First Posted: September 18, 2015
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
L.B.L. Benoist, Onze Lieve Vrouwe Gasthuis
  Purpose

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.


Condition Intervention
Positional Obstructive Sleep Apnea Device: Sleep position trainer Device: Mandibular advancement device Device: Continuous positive airway pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients

Resource links provided by NLM:


Further study details as provided by L.B.L. Benoist, Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • Apnea-hypopnea index (AHI) [ Time Frame: change from baseline, after 3, 6 and 12 months ]

Secondary Outcome Measures:
  • Outcome of Quality of Life questionnaires [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    EQ-5D

  • Outcome of Quality of Life questionnaires [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    Epworth Sleeping Scale (ESS)

  • Outcome of Quality of Life questionnaires [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    Functional Outcome Sleep Questionnaire (FOSQ)

  • (Societal) costs of treatment [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    iMTA Productivity Cost Questionnaire (iPCQ)

  • (Societal) costs of treatment [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    iMTA Medical Consumption Questionnaire (iMCQ)

  • Therapy compliance [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    Measurement of actual wearing time (in hours) per night

  • Cardiovascular parameters [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    Systolic and diastolic blood pressure

  • Cardiovascular parameters [ Time Frame: change from baseline, after 3, 6 and 12 months ]
    Pulse rate


Estimated Enrollment: 200
Actual Study Start Date: September 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553902


Contacts
Contact: A Beelen, MD a.beelen@olvg.nl
Contact: N de Vries, Professor n.vries@slaz.nl

Locations
Belgium
Antwerp University Hospital (UZA) Recruiting
Antwerp, Belgium
Contact: O.M. Vanderveken, Professor         
Netherlands
OLVG West Recruiting
Amsterdam, Netherlands
Contact: N. de Vries, Professor       n.vries@olvg.nl   
Contact: A Beelen, MD       a.beelen@olvg.nl   
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
University Hospital, Antwerp
Investigators
Principal Investigator: O.M. Vanderveken, Professor University Hospital, Antwerp
  More Information

Responsible Party: L.B.L. Benoist, Drs., Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT02553902     History of Changes
Other Study ID Numbers: NL52032.029.15
First Submitted: September 14, 2015
First Posted: September 18, 2015
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by L.B.L. Benoist, Onze Lieve Vrouwe Gasthuis:
Positional therapy
MAD
Oral appliance
Sleep position trainer
POSA

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases