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临床试验/NCT02953028
NCT02953028Unknown不适用

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 Tromso4 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
119
试验地点
4
主要终点
Association between patient characteristics and adherence to treatment With either CPAP or MAS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Severely compromised general health condition
  • Pregnancy
  • General health issues that disqualifies the use of CPAP and or MAS

研究组 & 干预措施

Continuous Positive Airway Pressure

Active Comparator

Patients treated With an auto-CPAP-machine which is a compressor Connected to a nose- or face mask which provides increased air pressure, opening the upper Airways during an apnea or hypopnea event.

干预措施: CPAP (Device)

Mandibular Advancing Splint

Active Comparator

Patients treated With a twin block splint (oral appliance) advancing the mandible and thereby opening the upper Airways for easier passage of air during sleep preventing apnea and hypopnea events.

干预措施: Mandibular Advancing Splint (Device)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Martin Berg

PhD-student

University of Tromso

研究点 (4)

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