Status:
ENROLLING_BY_INVITATION
Effectiveness of Inspiratory Muscle Training on Sleep in Patients With Obstructive Sleep Apnea
Lead Sponsor:
Universidade Federal de Pernambuco
Conditions:
Obstructive Sleep Apnea (OSA)
Sleep
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of inspiratory Muscle Training (IMT) on both objective and subjective sleep parameters in patients with OSA.Methods: A prospective, ran...
Detailed Description
Obstructive Sleep Apnea (OSA) is a prevalent sleep-related breathing disorder characterized by repeated episodes of upper airway obstruction during sleep, leading to intermittent hypoxia, sleep fragme...
Eligibility Criteria
Inclusion
- Male or female participants
- Age between 18 and 70 years
- Clinical diagnosis of moderate to severe Obstructive Sleep Apnea (OSA), confirmed by polysomnography
- Not currently undergoing treatment for OSA
Exclusion
- Presence of neuromuscular disorders, infectious diseases, immunological conditions, tumors, or any disease that prevents inspiratory muscle training (IMT), manovacuometry, or respiratory muscle performance assessment
- Unstable angina, untreated or uncontrolled systemic arterial hypertension, left ventricular dysfunction, cerebral aneurysm, or any cardiovascular condition contraindicating IMT or respiratory muscle testing
- Upper limb deformities that prevent the use of actigraphy devices or oximetry sensors
- Other sleep disorders (e.g., insomnia, hypoventilation syndrome, or need for continuous home oxygen therapy)
- Cognitive impairment that limits the participant's ability to understand or follow study procedures
- Ongoing or planned CPAP therapy during the follow-up period
- Participation in a pulmonary rehabilitation program within 6 months prior to the study
- Moderate or high physical activity level according to the IPAQ, including regular moderate or vigorous physical activity within the past 30 days
- Use of sleep-inducing medication to treat insomnia
- Grade 2 or 3 obesity (BMI ≥ 35 kg/m²)
- Residence in a geographic area with limited or no access to telephone or internet service, preventing contact or data transmission from study devices (actigraphy and/or oximetry sensors)
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07149233
Start Date
March 11 2025
End Date
February 20 2026
Last Update
August 29 2025
Active Locations (1)
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1
Cardiopulmonary Physiotherapy Laboratory
Recife, Pernambuco, Brazil, 50670-901