SPT is as effective as MRA in sleep-position dependent OSA
ID
Bron
Verkorte titel
Aandoening
OSA
obstructive sleepapnea
Ondersteuning
Somnomed
Mainly selffinancing
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
AHI (total and supine)<br>
ESS
Achtergrond van het onderzoek
SPT is expected to perform as wel as MRA in sleepposition dependent OSA. Patients will be treated sequentially with both therapies in 2 groupes. Group 1 will start with SPT for 3 months and then stop with SPT and start with MRA. The other group start with MRA and finishes with SPT, each for 3 months. After a total of 6 months patients can continue the treatment of choiceif effective and will undergo follow-up for 6 months.
Doel van het onderzoek
SPT is as effective as MRA in sleep-position dependent OSA
Onderzoeksopzet
3 months, 6 months, 12 months
Onderzoeksproduct en/of interventie
SPT (sleep position trainer)
MRA (mandibular rteatraction apparatus)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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 < 5/hour.
- AHI supine ¡Ý 2x AHI any other sleeping position
- ESS > 10
- Age 18-70 years of age
- Follow-up possible
- Ability to read and write
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6742 |
| NTR-old | NTR6920 |
| CCMO | NL28381.101.18 |