The Effect of Inspiratory Muscle Training on Cognitive Functions, Cerebral Oxygenation, and Neurotrophic Factor Level in Patients With Obstructive Sleep Apnea Syndrome

Summary

The aim of this clinical study is to examine the effect of an 8-week training program applied to the respiratory muscles that enable breathing in individuals with obstructive sleep apnea syndrome on cognitive functions, oxygenation of brain tissue, and the brain's healing and adaptation processes. The main questions it aims to answer are:

Does respiratory muscle training applied to individuals with obstructive sleep apnea syndrome have a beneficial effect on cognitive functions? Does respiratory muscle training applied to individuals with obstructive sleep apnea syndrome have a beneficial effect on brain oxygenation? Does respiratory muscle training applied to individuals with obstructive sleep apnea syndrome have a beneficial effect on the brain's healing and adaptation processes? A total of 42 individuals with obstructive sleep apnea syndrome will be included in the study. Researchers will compare the effectiveness of respiratory muscle training on individuals with obstructive sleep apnea syndrome by comparing the respiratory muscle training intervention with placebo (low-intensity respiratory muscle training) and usual care. At the beginning of the study, participants' demographic data will be recorded, they will be assessed, their blood will be drawn, and they will be asked to complete a questionnaire. Participants will be given an information brochure and a weekly follow-up form in addition to the necessary medical treatment.

Participants will receive the necessary medical treatment for 8 weeks, fill out the follow-up form provided every day and send it to the researcher once a week, perform inspiratory muscle training exercises for 8 weeks, and meet face-to-face with the researcher once a week.

The follow-up form will be checked every week. All assessments will be repeated at the end of the study.

Conditions

• Obstructive Sleep Apnea Syndrome (OSAS)

Interventions

DEVICE

inspiratory muscle training

In addition to the control group, IMT will be applied for 8 weeks, 7 days a week, twice a day for 15 minutes (30 breaths/3 sets/1-minute break between sets).The intensity of the training provided in IMT will be gradually increased over the 8 weeks.Before starting the training, patients' mouth pressure (MIP) will be measured and the training workload will be determined. During the first 2 weeks of training, 50% of MIP will be applied as the workload, 60% of MIP during weeks 3 and 4, and 75% of MIP during the last 4 weeks.During weekly face-to-face sessions, patients' new MIP values will be measured to determine the new workload.Patients will be given treatment diaries and asked to mark the sessions they have completed.They will be asked to bring these diaries to the physiotherapist once a week during face-to-face sessions. Additionally, during these sessions, patients' use of the IMT device will be checked, and if any errors are detected, device usage will be re-explained.

DEVICE

Placebo inspiratory muscle training

In addition to the control group, inspiratory muscle training at 15% of MIP will be administered twice daily for 15 minutes (30 breaths/3 sets/1-minute rest between sets) for 7 days a week over an 8-week period. Patients will be given treatment diaries and asked to mark their sessions and send these diaries to the physical therapist once a week.

OTHER

Usual Care

Individuals will receive standard medical treatment. They will be informed about their illnesses, what they need to do, and what they need to be mindful of. A disease-specific informational brochure and a follow-up form will be provided.

Sponsors & Collaborators

• Istinye University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-31

Primary Completion

2027-06-30

Completion

2027-09-30