Obstructive Sleep Apnea Management in People With Spinal Cord Injury

University Hospital, Motol

Status: Enrolling

Conditions: Spinal Cord Injuries; Obstructive Sleep Apnea

Treatments: Device: Mandibular Advancement Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04962165

SCI_APNEA_2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Experimental group

Experimental group

Description:

The group of SCI people will use a mandibular advancement device for treatment of obstructive sleep apnea.

Treatment:

Device: Mandibular Advancement Device