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Vergelijking van slaap positie trainer versus slaapbeugel


- candidate number28381
- NTR NumberNTR6920
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-dec-2017
- Secondary IDsNL28381.101.18 METC TWOR Maasstad
- Public TitleVergelijking van slaap positie trainer versus slaapbeugel
- Scientific TitleSleep position trainer versus MRA: a randomized controlled cross-over clinical trial
- ACRONYMSLEMRA
- hypothesisSPT is as effective as MRA in sleep-position dependent OSA
- Healt Condition(s) or Problem(s) studiedObstructive sleep apnea syndrome, Obstructive sleepapnea
- Inclusion criteria- Newly diagnosed OSA 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) [11]
- Apnea hypopnea index 6-29/hour
- Time in supine position 10-90 % during the night, AHI/ non supine < 5/hour.
- AHI supine 2x AHI any other sleeping position
- ESS > 10
- Age 18-70 years of age
- Follow-up possible
- Ability to read and write
- 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate31-jan-2019
- Target number of participants40
- InterventionsSPT (sleep position trainer)
MRA (mandibular rteatraction apparatus)
- Primary outcomeAHI (total and supine)
ESS
- Secondary outcome- 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
- Timepoints3 months, 6 months, 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Asin
- CONTACT for SCIENTIFIC QUERIES S. van der Kleij
- Sponsor/Initiator Amphia Hospital Breda
- Funding
(Source(s) of Monetary or Material Support)
Nightbalance (SPT), Somnomed
- Publicationsnone
- Brief summarySPT 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.
- Main changes (audit trail)Mainly selffinancing
- RECORD27-dec-2017 - 8-jan-2018


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