Obstructive Sleep Apnea Management in People With Spinal Cord Injury

Study Overview
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Brief Summary
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The prevalence of obstructive sleep apnea (OSA) is a significantly higher in people after spinal cord injury (SCI) than in the general population. As a positive pressure therapy (CPAP) is often poorly tolerated, a mandibular advancement device (MAD) can be used for the treatment of OSA. The purpose of this study is to determine the efficacy of MAD in people with SCI and to verify their adherence to the therapy.

Detailed Description
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Obstructive sleep apnea (OSA) is a disorder with serious health consequences. Compared to the general population, a significantly higher prevalence of OSA was found in individuals with spinal cord injury (SCI). As treatment, positive pressure therapy in the respiratory tract during sleep (CPAP) is commonly instituted. However, CPAP therapy is often rejected or poorly tolerated by patients. Alternatively, the American Association of Sleep Medicine recommends the use of Mandibular Advancement Devices (MAD). The MAD prevents the upper airway from collapsing by anterior displacement of the mandible. The aim of the project is to determine the efficacy of MAD therapy in people with SCI and to verify their adherence to the therapy. The research group will consist of 60-80 subjects. The selection of suitable participants will be based on the results of a polygram. The MAD for a group of subjects with an apnea-hypopnea index (AHI) higher than five will be fabricated using their dental impressions. Subsequently, the subjects will be retested while wearing the MAD and outcomes will be compared. The evaluation will include a set of questionnaires. Adherence to therapy will be checked after three and six months. The investigators anticipate that the results of the study will confirm the effectiveness of MAD devices in the treatment of OSA in the monitored group. Most importantly, the investigators intend to set a standard for a long-term system of diagnosing and addressing OSA in individuals with SCI.

Official Title
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Obstructive Sleep Apnea Management in People With Spinal Cord Injury, Treatment Options by Mandibular Advancement Device

Conditions
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Obstructive Sleep Apnea, Spinal Cord Injuries

Intervention / Treatment
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* Device: Mandibular Advancement Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AHI > 5 on polygraphy sufficient set of teeth to hold a splint written informed consent Exclusion Criteria: use of medication that could affect breathing or sleep oxygen-dependent or decompensated lung disease decompensated congestive heart failure evidence of other sleep disorders (narcolepsy, restless legs syndrome, insomnia) abnormalities of the upper airway periodontal problems and untreated caries mental disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The group of SCI people will use a mandibular advancement device for treatment of obstructive sleep apnea. | Device: Mandibular Advancement Device<br>* The device maintain opened upper airway by moving the lower jaw slightly forward while sleeping.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea index (AHI) | The obstructive Apnea-Hypopnea Index is defined as the mean number of obstructive apneas and hypopneas per hour of sleep, thus: the occurrence of 5 to 14 events per hour of sleep means presence of mild apnea, 15 to 29 moderate apnea and ≥ 30 severe apnea. The AHI is derived from overnight polygraphy. | through study completion, an average of 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime sleepiness | The Epworth sleepiness scale (ESS) will measure the subjective daytime sleepiness, assesses the propensity to sleep under inappropriate circumstances. The ESS questionnaire consists of 8 questions about daytime sleepiness in various situations. The minimum scale values of 0-7 indicate no likeliness of being abnormally sleepy, the maximum scale values of 16-24 indicate excessive sleepiness. | through study completion, an average of 6 month | 
| Quality of life measurement | The WHOQOL-BREF will be used to measure the quality of life. This instrument is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Scores range from 0 to 100 with 100 indicating a higher quality of life. | through study completion, an average of 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apnea, Spinal cord injury, Mandibular Advancement Device