Obstructive Sleep Apnea Management in People With Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    60
  • sponsor
    University Hospital, Motol
Updated on 22 August 2021
spinal cord
spinal cord disorder

Summary

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.

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.

Details
Condition obstructive sleep apnoea, Wounds, Trauma, Spinal Cord Injury, Obstructive sleep apnea, Myelopathy, obstructive sleep apnea syndrome, Spinal Cord Injuries, Spinal Cord Disorders
Treatment Mandibular advancement device
Clinical Study IdentifierNCT04962165
SponsorUniversity Hospital, Motol
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
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