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

NCT ID: NCT07329049

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-09-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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.

Placebo IMT group

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

Group Type: SHAM_COMPARATOR

Placebo inspiratory muscle training

Intervention Type: DEVICE

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.

IMT Group

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%.

Group Type: ACTIVE_COMPARATOR

inspiratory muscle training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Feyza Meraklı

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Feyza MERAKLI

Role: CONTACT

feyzamrkl@gmail.com

+905427685223

References

Cheng YY, Lin SY, Hsu CY, Fu PK. Respiratory Muscle Training Can Improve Cognition, Lung Function, and Diaphragmatic Thickness Fraction in Male and Non-Obese Patients with Chronic Obstructive Pulmonary Disease: A Prospective Study. J Pers Med. 2022 Mar 16;12(3):475. doi: 10.3390/jpm12030475.

Reference Type: BACKGROUND

PMID: 35330474 (View on PubMed)

Ferreira L, Tanaka K, Santos-Galduroz RF, Galduroz JC. Respiratory training as strategy to prevent cognitive decline in aging: a randomized controlled trial. Clin Interv Aging. 2015 Mar 20;10:593-603. doi: 10.2147/CIA.S79560. eCollection 2015.

Reference Type: BACKGROUND

PMID: 25848235 (View on PubMed)

Souza AKF, Dornelas de Andrade A, de Medeiros AIC, de Aguiar MIR, Rocha TDS, Pedrosa RP, de Lima AMJ. Effectiveness of inspiratory muscle training on sleep and functional capacity to exercise in obstructive sleep apnea: a randomized controlled trial. Sleep Breath. 2018 Sep;22(3):631-639. doi: 10.1007/s11325-017-1591-5. Epub 2017 Nov 9.

Reference Type: BACKGROUND

PMID: 29124630 (View on PubMed)

Nobrega-Junior JCN, Dornelas de Andrade A, de Andrade EAM, Andrade MDA, Ribeiro ASV, Pedrosa RP, Ferreira APL, de Lima AMJ. Inspiratory Muscle Training in the Severity of Obstructive Sleep Apnea, Sleep Quality and Excessive Daytime Sleepiness: A Placebo-Controlled, Randomized Trial. Nat Sci Sleep. 2020 Dec 2;12:1105-1113. doi: 10.2147/NSS.S269360. eCollection 2020.

Reference Type: BACKGROUND

PMID: 33293881 (View on PubMed)

Other Identifiers

2025/1362

Identifier Type: -

Identifier Source: org_study_id