OSA obstructive sleepapnea
Conditions
Interventions
SPT (sleep position trainer)
MRA (mandibular rteatraction apparatus)
Sponsors
Amphia ziekenhuis
Eligibility
Inclusion criteria
Inclusion criteria: - Newly diagnosed OSA patient (according to Dutch guidelines: AHI > 5/hr & ¡Ý 2 of the following complaints: faltering breathing during sleep, repeatedly startle awakening during sleep, non-refreshing sleep, daytime fatigue, concentrationloss) [11] - Apnea hypopnea index 6-29/hour - Time in supine position 10-90 % during the night, AHI/ non supine 10 - Age 18-70 years of age - Follow-up possible - Ability to read and write
Exclusion criteria
Exclusion criteria: - Central sleep apnea or significant central sleep apnea component - Unsuitable for MRA - Concentration disorder due to OSA potentially leading to dangerous situations - Reversible / treatable upper airway disease (i.e. enlarged tonsils) - Expectation of great change on physical status during study-period (for example condition with expected great change in bodyweight, pregnancy, operative treatment especially of the face, OSA-surgery, bariatric surgery) - Medication for sleep disorder or related to sleeping disorder. - Known comorbidity causing fatigue or severe sleep disturbances (insomnia, PLMS, narcolepsy) - Complains of loud snoring in non-supine position - Neck, shoulder or back problems - Patients with a diagnosed anxiety disorder - Mental disorder/retardation - Impossibility for informed consent - Nightshift-profession - Severe cardiac failure - Epilepsy - Simultaneous use of other treatment modalities for OSA - History of former treatment for OSA using MRA, CPAP or SPT - Combination therapy (weight reduction, ENT-surgery, CPAP) - Other reasons for a strong need for CPAP-therapy - BMI > 35 kg/m2. - Elevation off headside of the bedside more than 30 degrees or sleeping on more than two pillows
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AHI (total and supine) ESS | — |
Secondary
| Measure | Time frame |
|---|---|
| - Compliance (Somnomed dentitrac and Nightbalance) after 3 and 9 months of treatment - Mean disease alleviation (MDA) as the product of the adjusted compliance with the therapeutic efficacy divided by 100 (%)[17] - Total sleep time (TST) - Sleepposition, percentage of sleep in supine-position - FOSQ-10 questionaire (appendix ) - SF-36 questionaire (appendix ) - MFIQ (Mandibular function impairment questionnaire, appendix) - Total costs - Sleepposition (including % in supine position, as acquired by Zorginstituut Nederland) - Patient satisfaction (questionaires, numerical rating scale (NRS) / visual analoge scale (VAS), including sleepiness and fatigue) (appendix) - Snoring (patient / bedpartner reported NRS / VAS 0-10) - Patient anamnesis / diary (usage, hinder, alcoholusage) - Partner satisfaction (snoring, movement, disturbance of sleep due to therapyy, NRS 0-5) (appendix 19, 20) - Therapy preference - Sleepstages - Sleepefficiency - Adverse events | — |
Contacts
Public ContactJ. Asin
Outcome results
None listed