Obstructive Sleep Apnea - Patient Specific Factors, Success Rate and Compliance

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: CPAP
* Device: Mandibular Advancing Splint


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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Positive Airway Pressure<br>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. | Device: CPAP<br>* Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure<br>* Other names: Resmed Autoset S9;|
| Active Comparator: Mandibular Advancing Splint<br>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. | Device: Mandibular Advancing Splint<br>* Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea<br>* Other names: Somnodent Fusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between patient characteristics and adherence to treatment With either CPAP or MAS | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy. | Objective measurement of the efficacy of MAS or CPAP treatment in patients having mild or moderate OSA. Apnea-events/hypopnea-events and oxygen desaturation-index registered by respiratory polygraphy are combined to give an AHI-score before treatment and after 4 months of intervention. | 4 months | 
| Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy. | Objective measurement of the efficacy of MAS or CPAP treatment in patients having mild or moderate OSA. Apnea-events/hypopnea-events and oxygen desaturation-index registered by respiratory polygraphy are combined to give an AHI-score before treatment and after 12 months of intervention. | 12 months | 
| Self-reported patient compliance to MAS or CPAP collected by questionnaire | Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA | 4 months | 
| Self-reported patient compliance to MAS or CPAP collected by questionnaire | Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA | 12 months | 
| Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36) | Health related Quality of life at baseline and after 4 months of treatment with either MAS or CPAP in patients having mild or moderate OSA | 4 months | 
| Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36) | Health related Quality of life at baseline and after 12 months of treatment with either MAS or CPAP in patients having mild or moderate OSA | 12 months | 
| Self-reported symptoms of anxiety and/or depression collected by the questionnaire Hospital Anxiety and Depression Scale (HADS) | Self reported signs on depression and anxiety at baseline and after 4 months of treatment with either MAS or CPAP in patients having mild or moderate OSA | 4 months | 
| Self-reported symptoms of anxiety and/or depression through the questionnaire Hospital Anxiety and Depression Scale (HADS) | Self reported signs on depression and anxiety at baseline and after 12 months of treatment with either MAS or CPAP in patients having mild or moderate OSA | 12 months | 
| Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI) | Self perceived sleep quality at baseline and after 4 months of treatment with either MAS or CPAP in patients having mild or moderate OSA | 4 months | 
| Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI) | Self perceived sleep quality at baseline and after 12 months of treatment with either MAS or CPAP in patients having mild or moderate OSA | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Snoring, Continuous Positive Airway Pressure, Mandibular Advancing Splint, Efficacy, Compliance, Health related quality of life, Randomized Controlled Trial, Mandibular Advancing Appliance, Mandibular Advancing Device, Humans, Quality of Life, Sleep Apnea, Obstructive