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Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Onze Lieve Vrouwe Gasthuis
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
L.B.L. Benoist, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT02553902
First received: September 14, 2015
Last updated: September 17, 2015
Last verified: September 2015
  Purpose

OBJECTIVES:

To evaluate the effect and cost-utility of positional therapy comparing the sleep position trainer (SPT) with continuous positive airway pressure (CPAP), mandibular repositioning appliance (MRA) and the combination SPT and MRA in patients with moderate positional obstructive sleep apnea (POSA).

HYPOTHESIS:

The SPT is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP and MRA.

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, MRA, SPT 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 400 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 Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by 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: 400
Study Start Date: September 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sleep position trainer (SPT)
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. It makes use of a sleep-in period and a training program. To stimulate compliance, information is provided about nightly behaviour, implicating a learning pattern by viewing the data on a home computer.
Device: Sleep position trainer
Active Comparator: Continuous positive airway pressure (CPAP)
CPAP functions as a pneumatic splint to maintain upper airway patency. Possible side effect can be related to the interface (skin abrasion from contact with the mask, claustrophobia, mask leak, irritated eyes), pressure (nasal congestion and rhinorrhea with dryness or irritation of the nasal and pharyngeal membranes, sneezing, gastric and bowel distension, recurrent ear and sinus infections) and negative social factors.
Device: Continuous positive airway pressure
Active Comparator: Mandibular advancement
MRA or oral appliances (OA) have become increasingly popular as a treatment alternative. By advancing the mandible and its attached soft tissue structures forward they aim to increase upper airway size. Side effects have been reported with use of MRA: excessive salivation or dryness of the mouth, gum irritation, discomfort of the temparomandibular joint, teeth of facial musculature and bite change.
Device: Mandibular advancement device
Other Name: MRA
Active Comparator: Sleep position trainer + mandibular advancement
see above
Device: Sleep position trainer Device: Mandibular advancement device
Other Name: MRA

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02553902

Contacts
Contact: L Benoist, MD l.benoist@slaz.nl
Contact: N de Vries, Professor n.vries@slaz.nl

Locations
Belgium
Antwerp University Hospital (UZA) Not yet recruiting
Antwerp, Belgium
Contact: O.M. Vanderveken, Professor         
Netherlands
OLVG West Recruiting
Amsterdam, Netherlands
Contact: N. de Vries, Professor       n.vries@slaz.nl   
Contact: L. Benoist, MD       l.benoist@slaz.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
Study First Received: September 14, 2015
Last Updated: September 17, 2015

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

ClinicalTrials.gov processed this record on May 23, 2017