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| Name | Class |
|---|---|
| University Hospital of North Norway | OTHER |
| Public Dental Service Competence Centre of Northern Norway | UNKNOWN |
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tordis A. Trovik, PhD, DDS | University of Tromsø, Department of Community Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Olavs Hospital | Trondheim | Sør-Trøndelag | N-7006 | Norway | ||
| University Hospital of North Norway |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D010349 | Patient Compliance |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Mandibular Advancing Splint | Device | Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea |
|
|
| 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 |
| Tromsø |
| Troms |
| N-9038 |
| Norway |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |