Effectiveness of Inspiratory Muscle Training on Sleep in Patients With Obstructive Sleep Apnea

NCT07149233 | Enrolling By Invitation DMC

• 2 other identifiers: 7.330.179CAAE: 84723724.2.0000.5208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA); Sleep

Keywords

Obstructive Sleep Apnea; Inspiratory Muscle Training; Objective and Subjective Sleep Parameters

Outcome Measures

Primary Outcomes (2)

• sleep quality

  Sleep quality will be assessed using the PSQI. A score from 0 to 4 indicates good sleep quality, while a score above 5 indicates poor sleep quality

  Sleep quality will be assessed before and after four weeks of inspiratory muscle training

• daytime sleepiness

  Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS) before and after the four weeks of inspiratory muscle training (IMT). The scale consists of eight everyday situations, asking the individual to self-assess the likelihood of dozing off during these activities, scoring from 0 to 3, where 0: no chance of dozing, 1: slight chance, 2: moderate chance, and 3: high chance. A total score greater than 10 is used as the cutoff point to identify individuals with a high likelihood of excessive daytime sleepiness

  Daytime sleepiness will be assessed before and after four weeks of inspiratory muscle training

Secondary Outcomes (19)

• hypoxic burden

  The hypoxic burden will be assessed before and after four weeks of inspiratory muscle training

• Maximal Inspiratory Pressure (MIP)

  Baseline, weekly during intervention (for load adjustment), and post-intervention (4 weeks)

• Disease severity

  Disease severity will be assessed before and after four weeks of inspiratory muscle training.

• Physical activity level

  Assessment Before and after 4 weeks

• Respiratory endurance

  Assessment Before and after 4 weeks

Study Arms (2)

Group 1 - Inspiratory Muscle Training (IMT)

EXPERIMENTAL

Participants with moderate to severe obstructive sleep apnea (OSA) will perform inspiratory muscle training using a threshold device with progressive loading over 4 weeks. Training will begin at 50% of maximal inspiratory pressure (MIP) for the first 2 weeks, increase to 60% in week 3, and 75% in week 4. Participants will perform three sets of 30 fast, forceful inspiratory efforts, with one-minute rest intervals between sets. Training sessions will occur twice daily, seven days per week. Load adjustments will be made weekly during in-person visits. Participants will record adherence and occurrences in a training diary and will be monitored daily by the principal investigator through phone calls.

Device: Inspiratory Muscle Training

Group 2 - Sham Inspiratory Muscle Training

SHAM COMPARATOR

Participants in the control group will perform sham inspiratory muscle training using the same device with the internal spring removed, providing no resistance. The training protocol will mirror that of the intervention group: three sets of 30 fast inspiratory efforts, with one-minute rest intervals, performed twice daily, seven days per week, for 4 weeks. Weekly in-person visits will be held to verify procedures, and participants will log adherence in a training diary. Daily phone follow-ups will be conducted by the principal investigator.

Device: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training DEVICE

Inspiratory muscle training (IMT) was performed for 4 weeks in patients with moderate to severe OSA. The intervention group used a threshold device with resistance: training occurred twice daily, 7 days per week, with 3 sets of 30 fast inspiratory efforts and 1-minute rest between sets. Load started at 50% of maximal inspiratory pressure (MIP), increased to 60% in week 3, and 75% in week 4. Weekly visits were held for load adjustment. The sham group followed the same schedule using the same device without resistance (spring removed). Both groups recorded adherence in training diaries and received daily follow-up calls from the principal investigator

Group 1 - Inspiratory Muscle Training (IMT); Group 2 - Sham Inspiratory Muscle Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Cardiopulmonary Physiotherapy Laboratory

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (1)

• Aiello KD, Caughey WG, Nelluri B, Sharma A, Mookadam F, Mookadam M. Effect of exercise training on sleep apnea: A systematic review and meta-analysis. Respir Med. 2016 Jul;116:85-92. doi: 10.1016/j.rmed.2016.05.015. Epub 2016 May 21.

  PMID: 27296826 BACKGROUND

Related Links

• Brazilian platform for research project submission

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Armele D de Andrade, PhD Pneumo

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc student in Physical Therapy,Principal Investigator

Model Details: Eligible participants will be assessed before and after four weeks of Inspiratory Muscle Training (IMT). Data will be recorded in evaluation forms covering personal, clinical, anthropometric variables, and respiratory muscle strength and performance. Participants will complete the Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and International Physical Activity Questionnaire. Objective sleep data will be collected via actigraphy for nine days pre- and post-intervention, recorded in actigraphy forms. Nocturnal oximetry and polygraphy will also be performed before and after IMT, during the same weeks as actigraphy, and documented accordingly. IMT adherence will be self-reported in an IMT diary. After completing the intervention, participants will answer a questionnaire assessing perceived health changes and satisfaction with the treatment

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: August 29, 2025
• Study Start: March 11, 2025
• Primary Completion: December 20, 2025
• Study Completion: February 20, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary study results, for a period of up to 5 years.
• Access Criteria: Researchers must submit a detailed research proposal and obtain approval from the principal investigator.

Locations

BR (1)