Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02553902
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02553902
Study Brief:
Protocol Section:
NCT02553902