Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep Apnea
A legfontosabb adatok
- Ki végzi
- University of Copenhagen
- Hol
- Copenhagen (Dánia)A helyszín megnézése
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 70 fő, tervezett
- Kezdés
- 2026. aug.
- Várható befejezés
- 2029. aug.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Mandibular advancement device (MAD)
- Continuous positive airway pressure (CPAP)
- A regiszteradat frissítve
- 2026. június 30.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 23 feltétel megnézéseKevesebb
Ki vehet részt
- Objectively diagnosed with moderate OSA (AHI 15-29)
- >/= 18 years
- BMI </= 35 and neck circumference <44cm
- Fully sanitised at their own dentist (no periodontitis or caries requiring treatment. Periodontal bone loss <50%)
- >/= 20 teeth
- Evenly distributed occlusal contacts
Ki nem vehet részt
- Prior blood clot in the brain or in the heart
- General inflammatory joint diseases
- Conditions demanding treatment such as temporomandibular disorders (TMD)
- Heart arrythmias
- Other severe systemic diseases
- Allergies towards peanuts, soy or egg
- Known craniofacial anomalies
- Maximal protrusion of the mandible < 6 mm
- Severe deep bite
- Anterior open bite
- Severe attrition
- Severe bruxism and involuntary mandibular movements
- Chronically pronounced nasal stenosis
- Hypertrophic tonsils (tonsil size 3-4)
- Epilepsia
- Consumption of morphine or other sedatives which cannot be paused
- Pregnant or breast-feeding women
Helyszínek itt: Dánia
- University of CopenhagenCopenhagen, DániaContact: Clara Hartogsohn, PhD StudentNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
Obstructive sleep apnea (OSA) is a frequent illness related to sleep and breathing with many symptoms and complications. The primary choices of treatment are continuous positive airway pressure (CPAP) and removable appliance for protruding the mandible when sleeping (MAD). Treatment with CPAP is superior to treatment with MAD but many patients don't tolerate CPAP why they seek treatment with MAD. In Denmark, treatment with MAD is not free of charge unlike treatment with CPAP and MAD is therefore not offered systematically to the patients. The same applies to adjustment, control and effect of the MAD treatment. MAD treatment has a positive effect on OSA in general but the effect varies due to differences in selection of patients and lack of specifying who performs and evaluates MAD treatment, the effect on sleep and possible side effects in muscles and the temporomandibular joint as well as the occlusion during treatment. It is therefore of great importance to investigate the effect of MAD treatment as well as short- and long-term side effects. The aim is therefore to compare the treatment effect of MAD and CPAP and how significant the investigation of the airways and the face is for the treatment effect and possible side effects. The project is a 4-year investigation and 70 adult patients diagnosed with moderate OSA are included. The results from the investigation will be of great importance for the choice of treatment and prognosis for the individual patient and socio-economic since the treatment of OSA could be tailored the individual patient and the treatment effect optimised.
A vizsgálat 2 csoportja
- MAD-groupA vizsgált kezelés
Group starting with the MAD treatment
Kezelés: Mandibular advancement device (MAD) és Continuous positive airway pressure (CPAP)
- CPAP-groupA vizsgált kezelés
Group starting with the CPAP treatment
Kezelés: Mandibular advancement device (MAD) és Continuous positive airway pressure (CPAP)
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Obstructive Sleep Apnea
- A regiszteradat frissítve
- 2026. június 30.