The Role of the Device Operating Under the Continuous Positive Airway Pressure in the Recovery Process of Cochlea

Summary

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:

1. To determinate whether there is cochlear receptor cells damage in OSAS patients depending on the degree of the disease
2. 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.

Conditions

• Obstructive Sleep Apnea

Interventions

DEVICE

DEVICE OPERATING UNDER THE CONTINOUS POSITIVE AIRWAY PRESSURE

The principle of operation is to prevent the closure and the narrowing of the structures of the upper respiratory tract by applying positive pressure. The device consists of a mask that protects the nose and/or mouth, a tube that connects the mask to the monitor and a monitor that blows air into the tube. A pressure in the range of 4 to 20 cm water is applied, depending on the individual needs of the patient to keep the airway open. The use is considered to be effective when the patient uses it continuously for at least 4 hours at bedtime. Today's modern devices have memory cards for storing data on the regularity and time of use of the device during the night and the efficiency of the device itself. For therapy to be considered effective, the number of apneas and hypopneas must be less than 5 per hour of sleep.

Sponsors & Collaborators

• Mirjana Grebenar Cerkez

  lead OTHER

Principal Investigators

• Darija Birtic · Department of Otorhinolaryngology and Head and Neck Surgery Osijek

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-02

Primary Completion

2024-04-30

Completion

2024-11-30

Countries

• Croatia

Study Locations