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Clinical Trials/NCT02953028
NCT02953028
Unknown
Not Applicable

Treatment of Mild and Moderate Obstructive Sleep Apnea (OSA) by Continuous Positive Airway Pressure (CPAP) or Mandibular Advancing Splint (MAS) - a Randomized Controlled Trial on Patient Specific Factors, Success Rate and Compliance

University of Tromso2 sites in 1 country119 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea, Obstructive
Sponsor
University of Tromso
Enrollment
119
Locations
2
Primary Endpoint
Association between patient characteristics and adherence to treatment With either CPAP or MAS
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lars Martin Berg

PhD-student

University of Tromso

Eligibility Criteria

Inclusion Criteria

  • 10 ≤ Apnea-Hypopnea-Index ≤ 30 at baseline
  • Subjective symptoms of OSA
  • Ability of at least 5mm protrusion of the mandible
  • Accept randomization of treatment modality
  • Accept to fill in the questionnaires
  • Accept to attend at planned consultations

Exclusion Criteria

  • Primarily central sleep apnea
  • Known temporomandibular dysfunction (TMD)
  • Mental instability
  • Drug abuse
  • Extensive usage of sedative medication which disqualifies for OSA-treatment
  • Extensive gag-reflex or claustrophobia
  • Inadequate dental support (\< 10 teeth in lower jaw)
  • Inadequate periodontal support (no tooth mobility \> Miller grade I)
  • Anatomical abnormalities in the nasal cavity or oro-pharynx that disqualifies the use of CPAP and/or MAS
  • Anatomical abnormalities which should be surgically corrected before treatment with CPAP and/or MAS

Outcomes

Primary Outcomes

Association between patient characteristics and adherence to treatment With either CPAP or MAS

Time Frame: 12 months

Combining measurements from questionnaires at baseline and 12 months to map the patient characteristics of those patients treated for mild or moderate OSA who comply, or do not comply to CPAP-intervention or MAS-intervention respectively. Detailed description of measurements collected are listed in secondary outcome measures.

Secondary Outcomes

  • Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)(12 months)
  • Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.(12 months)
  • Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)(12 months)
  • Self-reported patient compliance to MAS or CPAP collected by questionnaire(12 months)
  • Self-reported symptoms of anxiety and/or depression collected by the questionnaire Hospital Anxiety and Depression Scale (HADS)(4 months)
  • Self-reported symptoms of anxiety and/or depression through the questionnaire Hospital Anxiety and Depression Scale (HADS)(12 months)

Study Sites (2)

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