Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON48802
NL-OMON48802
Completed
Not Applicable

The use of a boil and bite Mandibular Advancement Device versus a custom Mandibular Advancement Device in Obstructive Sleep Apnea management - BOBYTE study

OLVG0 sites58 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
OLVG
Enrollment
58
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
OLVG

Eligibility Criteria

Inclusion Criteria

  • •\* OSA patient confirmed by a PSG
  • •\* 18 years and older
  • •\* Sufficient understanding of Dutch language in speaking and writing
  • •\* Included in DISE study with METc protocol ARB 66070, NL66070\.100\.18

Exclusion Criteria

  • •Medical and psychological criteria:
  • •\* Clear failure or non\-acceptance of previous MAD therapy
  • •\* Central Sleep Apnea syndrome ( \> 50% of central apneas)
  • •\* Inability to provided informed consent
  • •\* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils),
  • •Dental criteria:
  • •\* Extensive periodontal disease or tooth decay (confirmed by Xray).
  • •\* Active temporomandibular joint disease (including severe bruxism).
  • •\* Restrictions in mouth opening (\<25 mm) or advancement of the mandible (\<5 mm).
  • •\* Partial or complete edentulism (less than 8 teeth in upper or lower jaw).

Outcomes

Primary Outcomes

Not specified

Similar Trials

Not yet recruiting
Not Applicable
Het verschil tussen een tijdelijke en een op maat gemaakte uitneembare beugel voor de behandeling van slaapapneu
NL-OMON28622Academic Center Dentistry Amsterdam (ACTA)58
Completed
Not Applicable
Jaw thrust versus the use of a boil and bite mandibular advancement device as a screening tool during drug-induced sleep endoscopy.Obstructief slaapapneuOSAsleep apnea
NL-OMON50627KNO180
Recruiting
Not Applicable
Jaw thrust versus the use of a boil and bite mandibular advancement device as a screening tool during drug-induced sleep endoscopy.Obstructive sleep apnea (OSA, drug-induced sleep endoscopy (DISE), jaw thrust, mandibular advancement device (MAD)
NL-OMON25469OLVG100
Not yet recruiting
Not Applicable
Mouthguard and positional trainer( vibrating collar) in supine sleep apnoea..Ostructive sleep apnoeaPositional obstructive sleep apnoeasupine predominant sleep apnoeapositional sleep apnoea
ACTRN12618000207213Shyamala Pradeepan20
Completed
Not Applicable
Effectiveness of a titratable mandibular advancement splint for the treatment of obstructive sleep apnoeaObstructive Sleep ApnoeaRespiratory - Sleep apnoea
ACTRN12606000464561Dr Alister Neill, Primary investigator40