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

Istinye University

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea Syndrome (OSAS)

Treatments: Other: Usual Care; Device: inspiratory muscle training; Device: Placebo inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT07329049

2025/1362

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with moderate OSA using polysomnography
• Aged 18-60
• Not using non-invasive mechanical ventilation (NIMV)
• General health status is stable (The participant does not have an acute -cardiovascular, respiratory, metabolic, or neurological disease; has not experienced a condition requiring hospitalization in the last three months)
• No mental problems that would interfere with cooperation

Exclusion criteria

• History of oropharyngeal surgery
• Presence of any neurological, psychological, or cardiac disease
• BMI ≥40 kg/m²
• Presence of hypothyroidism, uncontrolled hypertension, and diabetes
• Having severe obstructive nasal disease
• Being pregnant
• Having cognitive problems
• Having overlap syndrome
• Using drugs, alcohol, sedatives, and hypnotic medications

Exclusion criteria after the study began:

• Exercise group participants with <75% attendance at training sessions
• Failure to attend sessions for 2 consecutive weeks during the treatment period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 3 patient groups

Control Group

Other group

Description:

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.

Treatment:

Other: Usual Care

Placebo IMT group

Sham Comparator group

Description:

In addition to the control group, individuals will undergo low-resistance IMT at 15% of maximum inspiratory pressure every day for 8 weeks.

Treatment:

Device: Placebo inspiratory muscle training

IMT Group

Active Comparator group

Description:

Individuals will undergo IMT for 8 weeks in addition to the control group. Resistance will start at 50% of MIP and be gradually increased to 75%.

Treatment:

Device: inspiratory muscle training