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临床试验/NCT04962165
NCT04962165招募中不适用

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

University Hospital, Motol2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Apnea-Hypopnea index (AHI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AHI > 5 on polygraphy
  • sufficient set of teeth to hold a splint
  • written informed consent

排除标准

  • 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

结局指标

主要结局

Apnea-Hypopnea index (AHI)

时间窗: through study completion, an average of 6 month

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.

次要结局

  • Daytime sleepiness(through study completion, an average of 6 month)
  • Quality of life measurement(through study completion, an average of 6 month)

研究者

发起方
University Hospital, Motol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Assoc. Prof. Jiri Kriz, MD, PhD

Clinical Professor

University Hospital, Motol

研究点 (2)

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