Clinical Trials Logo

Clinical Trial Summary

Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during sleep due to collapse of the oro-pharynx. The consequences are reduced quality of sleep, increased risk for developing cardiovascular disease and increased risk of accidents caused by daytime sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to 16%. The golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP). This is effective and must be used for life. However, CPAP-treatment might be uncomfortable for the patient, with poor compliance as a result. An alternative is Mandibular Advancing Splints (MAS), which is perceived as less troublesome and may initiate higher compliance. Through mapping of patient characteristics, the researchers investigate which patient-type benefits most from two different treatment-devices. The aim of the study is to assess how the MAS treatment differ from the CPAP treatment in respect to efficacy, compliance and impact on health related quality of life among patient diagnosed with mild/moderate OSA. All OSA patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital, Northern-Norway (UNN) and St.Olavs Hospital were invited to participate in the study. The sample size at completion of the study should be 140 patients. Participants in the trial were randomly allocated to the two treatment groups, and assessed after 4 and 12 months of treatment. Data were collected through anamnesis, clinical examination, clinical photos, radiographs and questionnaires concerning general health related quality of life (SF36), oral health, cognitive aspects (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's Sleepiness scale) and compliance.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02953028
Study type Interventional
Source University of Tromso
Contact
Status Active, not recruiting
Phase N/A
Start date October 2014
Completion date December 2020

See also
  Status Clinical Trial Phase
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT04912635 - Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo N/A
Not yet recruiting NCT05939934 - Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal N/A
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Completed NCT02088723 - Testing the Elevation as Sleep Apnea Treatment N/A
Terminated NCT02269774 - Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea N/A
Completed NCT02261857 - 3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea Early Phase 1
Completed NCT01181570 - Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea Phase 4
Completed NCT01943708 - Novel Auto-continuous Positive Airway Pressure (CPAP) Validation Phase 3
Completed NCT00273754 - The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). Phase 2
Recruiting NCT02166879 - Undetected Sleep Apnea in the Postanesthesia Acute Care Unit (PACU)
Recruiting NCT04963192 - Integrated Management of Chronic Respiratory Diseases N/A
Completed NCT04846400 - Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia N/A
Completed NCT05056766 - How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
Recruiting NCT04314492 - Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults N/A
Completed NCT05175287 - OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Active, not recruiting NCT03431038 - Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH N/A
Enrolling by invitation NCT03075787 - Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea N/A
Completed NCT03300037 - HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor N/A
Recruiting NCT06097949 - AcuPebble to Remotely Monitor Patients With OSA on CPAP Therapy