The Role of the Device Operating Under the Continuous Positive Airway Pressure in the Recovery Process of Cochlear Receptor Cells in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Hearing test Otoacoustic Emission (TEOAE and DPOAE)
研究概览
简要总结
Hypothesis: Patients with obstructive sleep apnea syndrome (OSAS) have cochlear receptor cells damage because of prolonged, recurrent hypoxia. The use of devices operating under the continous positive airway pressure (CPAP) leads to the recovery of cochlear receptor cells.
Aims:
- To determinate whether there is cochlear receptor cells damage in OSAS patients depending on the degree of the disease
- Investigate whether the use of ventilation devices with continuous positive pressure and constant oxygen pressure in the airways can lead to the recovery of the cochlear receptor cells Participants and Methods: The investigation work will be designed as original scientific research- prospective cohort study at Department od Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Osijek.
The participants will be divided in two groups: target group with obstructive sleep apnea (n45) and control group with healthy individuals (n32).
Research plan: All participating in this study will complete the following questionnaires: STOP- BANG and Epworth drowsiness scale. Subjects of the target group with moderate or severe obstructive sleep apnea will be referred to an otorhinolaryngologist audiologist for complete examination and processing after examination by a neurologist. These participants will be examined by an audiologist after 6-8 months of continuous and adequate use of the CPAP device for reevaluation. Participants of a control group will be patients examined or treated in Department of Otorhinolaryngology and Head and Neck surgery for other diseases in whom specific questionnaires excluded the existence of obstructive sleep apnea. Audiological diagnostics will be performed on all patients on the same devices of the Department of Audiology and Phoniatrics .
Expected scientific contribution: To prove the existence of receptor hearing impairment in the patients with obstructive sleep apnea; and then to prove that the use of a of continuous positive airway pressure with constant oxygen pressure in patients with OSAS using CPAP devices leads to the recovery of the cochlear receptor cells whose damage occurred as a result prolonged recurrent hypoxia. In addition, to determine the importance of a broader diagnostic processing of patients with obstructive sleep apnea.
详细描述
The participants will be divided in two groups: target (n45) and control group (n32). The target group will consist of patients with OSAS who have been previously examined by a neurologist for sleep disorders, have undergone polysomnography, and have been diagnosed with moderate or severe obstructive sleep apnea according to the Apnea Hypopnea Index (AHI) : the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour./hypopnea index). The control group will consist of subjects in whom specific questionnaires excluded the existence of obstructive sleep apnea. Exclusive criteria are age less than 18 years, persons with previous neurootological diseases that required surgical treatment, and persons who deviate from the research protocol.
Research plan: All participants in this study will complete the following questionnaires:
- STOP-BANG :
Snoring ? Do you Snore Loudly (loud enough to be heard through closed doors or your bed-partner elbows you for snoring at night)? Yes or No Tired ? Do you often feel Tired, Fatigued, or Sleepy during the daytime (such as falling asleep during driving or talking to someone)? Yes or No Observed ?Has anyone Observed you Stop Breathing or Choking/Gasping during your sleep ? Yes or No Pressure ? Do you have or are being treated for High Blood Pressure ? Yes or No Body Mass Index more than 35 kg/m2? Yes or No Age older than 50 ? Yes or No Neck size large ? (Measured around Adams apple) Is your shirt collar 16 inches / 40cm or larger? Yes or No Gender = Male ? Yes or No Results: OSA - Low Risk : Yes to 0 - 2 questions OSA - Intermediate Risk : Yes to 3 - 4 questions OSA - High Risk : Yes to 5 - 8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference 16 inches / 40cm 2. Epworth sleepiness scale How Sleepy Are You?
How likely are you to doze off or fall asleep in the following situations? You should rate your chances of dozing off, not just feeling tired. Even if you have not done some of these things recently try to determine how they would have affected you. For each situation, decide whether or not you would have:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with OSAS who have been previously examined by a neurologist for sleep disorders, have undergone polysomnography, and have been diagnosed with moderate or severe obstructive sleep apnea according to the AHI index
- •Healthy individuals for control group that will consist of subjects in whom specific questionnaires excluded the existence of obstructive sleep apnea.
排除标准
- •age less than 18 years,
- •persons with previous neurootological diseases that required surgical treatment
- •persons who deviate from the research protocol.
结局指标
主要结局
Hearing test Otoacoustic Emission (TEOAE and DPOAE)
时间窗: 45 minutes for each participant initialy and then after six to eight months of using device new measurement
Objective analysis of hearing using otoacoustic emission in decibels. It is an objective method; it is performed by placing a probe with a plastic insertion into the subject's external ear canal and by recording the returning sound (an echo) with a sensitive microphone; the echo occurs in cases where the middle ear and cochlea i.e. cochlear receptor cells are healthy; the TEOAE shows the status of the whole cochlea, while the DPOAE examines more specific frequency regions.
次要结局
未报告次要终点
研究者
Mirjana Grebenar Cerkez
Mirjana Grebenar Cerkez, M.D. ENT specialist, audiologist
Osijek University Hospital