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

NCT05362890 | Unknown

• 1 other identifier: OSIJEKUH-OAE-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Cochlear receptor cells; Hearing; CPAP device; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Hearing test Otoacoustic Emission (TEOAE and DPOAE)

  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.

  45 minutes for each participant initialy and then after six to eight months of using device new measurement

Study Arms (2)

Patients with obstructive sleep apnea

EXPERIMENTAL

Patients with OSAS who have been previously examined by a neurologist for sleep disorders, have undergone polysomnography, and have been diagnosed with moderate severe obstructive sleep apnea according to the AHI index

Device: DEVICE OPERATING UNDER THE CONTINOUS POSITIVE AIRWAY PRESSURE

Control Group

NO INTERVENTION

The control group will consist of subjects in whom specific questionnaires excluded the existence of obstructive sleep apnea.

Interventions

DEVICE OPERATING UNDER THE CONTINOUS POSITIVE AIRWAY PRESSURE DEVICE

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.

Also known as: CPAP

Patients with obstructive sleep apnea

Eligibility Criteria

• Age: 25 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• age less than 18 years,
• persons with previous neurootological diseases that required surgical treatment
• persons who deviate from the research protocol.

Sponsors & Collaborators

• Mirjana Grebenar Cerkez: lead

Study Sites (1)

Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Osijek

Osijek, Croatia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypoxia

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Darija Birtic

  Department of Otorhinolaryngology and Head and Neck Surgery Osijek

  STUDY CHAIR

Central Study Contacts

Mirjana Grebenar Čerkez

CONTACT

+38598682429; mirjanagrebenar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mirjana Grebenar Cerkez, M.D. ENT specialist, audiologist

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: May 2, 2022
• Primary Completion: April 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 24, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be available upon completion of research for 12 months long
• Access Criteria: The information will be shared with other potential researchers for further analyses

Locations

CR (1)