Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02553902
• Date of registration: 14/09/2015
• Prospective Registration: No
• Primary sponsor: Onze Lieve Vrouwe Gasthuis
• Public title: Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
• Scientific title: Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients
• Date of first enrolment: September 2015
• Target sample size: 200
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02553902
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium, Netherlands

Contacts

• Name: Patty Vonk, MD

• Name: O.M. Vanderveken, Professor
• Affiliation: University Hospital, Antwerp

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Positional Obstructive Sleep Apnea

Intervention(s)

Device: Mandibular advancement device

Device: Continuous positive airway pressure

Device: Sleep position trainer

Primary Outcome(s)

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

Secondary Outcome(s)

Outcome of Quality of Life questionnaires [Time Frame: change from baseline, after 3, 6 and 12 months]

Therapy compliance [Time Frame: change from baseline, after 3, 6 and 12 months]

(Societal) costs of treatment [Time Frame: change from baseline, after 3, 6 and 12 months]

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

Secondary ID(s)

NL52032.029.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Antwerp