Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT07149233
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-29
First Post:
2025-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Inspiratory Muscle Training on Sleep in Patients With Obstructive Sleep Apnea
Sponsor:
Universidade Federal de Pernambuco
Organization:
Study Overview
Official Title:
Effectiveness of Inspiratory Muscle Training on Objective and Subjective Sleep Parameters in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, randomized, controlled clinical trial will be conducted with patients diagnosed with OSA followed at Otavio de Freitas Hospital. Participants will be evaluated for excessive daytime sleepiness (Epworth Sleepiness Scale), sleep quality (Pittsburgh Sleep Quality Index), physical activity level (IPAQ), sleep latency, total sleep time, sleep efficiency, number of nocturnal awakenings, total time in bed, total wake time during sleep (Actigraphy), hypoxic burden during sleep (Nocturnal Oximetry), disease severity (Polysomnography), respiratory muscle strength (Manovacuometry), and respiratory muscle endurance (Powerbreathe K-series) before and after 4 weeks of training, as well as perceived change in health status after IMT (PGIC).Participants will be divided into two groups and will perform IMT for 4 weeks: the experimental group will perform IMT with a progressive weekly load (50%, 60%, 75% of MIP) adjusted using the Powerbreathe® Classic device, while the control group will use the device without load. The participants will perform IMT at home under the guidance of the principal investigator.Statistical Analysis: Data will be analyzed using SPSS version 26.0 with descriptive and analytical statistical techniques. Normality will be assessed using the Shapiro-Wilk test. For intergroup and intragroup comparisons, two-way ANOVA will be used. Tukey's post-hoc test will be applied to compare pre- and post-intervention mean variances for each group. The level of significance adopted for all analyses will be 95% (p \< 0.05).Expected Results: It is expected that 4 weeks of IMT in patients with OSA will reduce excessive daytime sleepiness, sleep latency, number of awakenings, and hypoxic burden, as well as increase sleep efficiency and total sleep time, leading to improved sleep quality.
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 fragmentation, and frequent arousals. These events disrupt sleep architecture, reduce total sleep time and sleep efficiency, and result in non-restorative sleep. As a consequence, patients often present with excessive daytime sleepiness, cognitive and functional impairments, and an increased risk of occupational errors and motor vehicle accidents.
The impact of OSA extends beyond sleep, contributing to reduced quality of life and increased cardiovascular and metabolic risks. Considering the multifactorial consequences of OSA and the barriers to continuous positive airway pressure (CPAP) adherence-including cost, discomfort, and access-there is a need for alternative or adjunctive low-cost therapies that are easy to implement and have proven efficacy.
Inspiratory Muscle Training (IMT) has emerged as a promising therapeutic strategy to improve respiratory muscle strength, reduce symptoms, and potentially enhance sleep quality. However, evidence regarding its impact on objective and subjective sleep parameters in patients with OSA remains limited.
This study aims to evaluate the efficacy of a 4-week IMT protocol, following standardized training guidelines, in adults with moderate to severe OSA who have not yet initiated CPAP therapy. Validated instruments will be used to assess sleep outcomes. The findings are expected to contribute to clinical decision-making and offer evidence for non-pharmacological, non-invasive interventions to improve sleep quality and reduce daytime symptoms in this population.
The impact of OSA extends beyond sleep, contributing to reduced quality of life and increased cardiovascular and metabolic risks. Considering the multifactorial consequences of OSA and the barriers to continuous positive airway pressure (CPAP) adherence-including cost, discomfort, and access-there is a need for alternative or adjunctive low-cost therapies that are easy to implement and have proven efficacy.
Inspiratory Muscle Training (IMT) has emerged as a promising therapeutic strategy to improve respiratory muscle strength, reduce symptoms, and potentially enhance sleep quality. However, evidence regarding its impact on objective and subjective sleep parameters in patients with OSA remains limited.
This study aims to evaluate the efficacy of a 4-week IMT protocol, following standardized training guidelines, in adults with moderate to severe OSA who have not yet initiated CPAP therapy. Validated instruments will be used to assess sleep outcomes. The findings are expected to contribute to clinical decision-making and offer evidence for non-pharmacological, non-invasive interventions to improve sleep quality and reduce daytime symptoms in this population.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CAAE: 84723724.2.0000.5208 | OTHER | Federal University of Pernambuco | View |