No registrations found.
ID
Source
Brief title
Health condition
OSA
obstructive sleepapnea
Sponsors and support
Somnomed
Mainly selffinancing
Intervention
Outcome measures
Primary outcome
AHI (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
Background summary
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.
Study objective
SPT is as effective as MRA in sleep-position dependent OSA
Study design
3 months, 6 months, 12 months
Intervention
SPT (sleep position trainer)
MRA (mandibular rteatraction apparatus)
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 < 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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6742 |
| NTR-old | NTR6920 |
| CCMO | NL28381.101.18 |