positional / supine dependent sleep apneu / shallow breathing
Conditions
Interventions
Sleep-position trainer (SPT)
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Newly diagnosed OSAS patient (according to Dutch guidelines: AHI > 5/hr & * 2 of the following complaints: faltering breathing during sleep, repeatedly startle awakening during sleep, non-refreshing sleep, daytime fatigue, concentrationloss) - 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 OSAS 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, OSAS-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 OSAS - History of former treatment for OSAS using MRA, CPAP or SPT - Combination therapy (weight reduction, ENT-surgery, CPAP) - Other reasons for a strong need for CPAP-therapy - Expected other changes in physical well-being cause of comorbidity/other diseases and/or expected weight loss or gain such as pregnancy and bariatric surgery. - 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 |
|---|---|
| - Apneu-hypopneu index (AHI using PSG) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Oxygen desaturation index (ODI in PSG) - AHI in supine position (PSG) - Eppworth sleepiness scale (ESS questionnaire) - 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 (%) - Total sleep time (TST in PSG) - Sleepposition, percentage of sleep in supine-position (PSG) - FOSQ-10 - SF-36 - Total costs - MFIQ (Mandibular function impairment questionnaire) - Sleepposition (including % in supine position, PSG, nightbalance, DentiTrac) - Patient satisfaction (questionaires, numerical rating scale (NRS) / visual analoge scale (VAS), including sleepiness and fatigue) - Snoring (patient / bedpartner reported NRS / VAS 0-10) - Patient anamnesis / diary (usage, hinder, alcoholusage) - Partner satisfaction (snoring, movement, disturbance of sleep due to therapy) - Therapy preference (questionnaire) - Sleepstages (PSG) - Sleepefficiency (PSG) - Adverse events | — |
Countries
Netherlands
Outcome results
None listed