Obstructive Sleep Apnea (OSA)NCT07149233
Effectiveness of Inspiratory Muscle Training on Sleep in Patients With Obstructive Sleep Apnea
A study testing Inspiratory Muscle Training in people with Obstructive Sleep Apnea (OSA) and Sleep, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Sleep
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Cardiopulmonary Physiotherapy Laboratory
Recife, Pernambuco, 50670-901
About this study
Official title: Effectiveness of Inspiratory Muscle Training on Objective and Subjective Sleep Parameters in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea (OSA), Sleep
- Being tested
- Inspiratory Muscle Training
- Keywords
- Obstructive Sleep Apnea, Inspiratory Muscle Training, Objective and Subjective Sleep Parameters
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Daytime sleepiness will be assessed before and after four weeks of inspiratory muscle training
Secondary outcomes (19)
hypoxic burden
To assess peripheral oxygen saturation (SpO2) levels during sleep, a sleep study will be conducted using a high-resolution wireless pulse oximeter. The collected data are automatically transferred to a cloud service where they are analyzed by an algorithm.
Measured: The hypoxic burden will be assessed before and after four weeks of inspiratory muscle training
Maximal Inspiratory Pressure (MIP)
Inspiratory muscle strength assessed by POWERbreathe KH2 in testing mode. The evaluation will be performed weekly during the intervention period to adjust training loads, and at baseline and post-intervention for analysis purposes; Unit of measure: cmH₂O
; Assessment tool: POWERbreathe KH2/K5
Measured: Baseline, weekly during intervention (for load adjustment), and post-intervention (4 weeks)
Disease severity
Disease severity will be assessed through polygraphy before and after the four weeks of inspiratory muscle training (IMT) in the study participants. The ApneaLink device (ResMed) will be used to evaluate disease severity
Measured: Disease severity will be assessed before and after four weeks of inspiratory muscle training.
Physical activity level
Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ), an instrument that estimates weekly energy expenditure from physical activities related to work, transportation, household tasks, and leisure.The IPAQ classification divides and defines physical activity levels into the following categories: low, moderate, or high
Measured: Assessment Before and after 4 weeks
Respiratory endurance
Unit of measurement: (cmH₂O); Assessment tool: Powerbreathe KH2/K5
Measured: Assessment Before and after 4 weeks
Fatigue Index Strength
Unit of measurement: (cmH₂O); Assessment tool: Powerbreathe KH2/K5
Measured: Assessment Before and after 4 weeks
Peak inspiratory flow
Unit of measurement: (liters/second); Assessment tool: Powerbreathe KH2/K5
Measured: Assessment Before and after 4 weeks
Energy inspiratory
Unit of measurement: (joules); Assessment tool: Powerbreathe KH2/K5
Measured: Assessment Before and after 4 weeks
Volume inspiratory
Unit of measurement: (liters); Assessment tool: Powerbreathe KH2/K5
Measured: Assessment Before and after 4 weeks
Bedtime
Bedtime assessed objectively by actigraphy; Unit of measure: hours ;Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Wake-up time
Wake-up time assessed objectively by actigraphy; Unit of measure: hours; Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Sleep latency
nterval between bedtime and sleep onset measured by actigraphy.
nterval between bedtime and sleep onset measured by actigraphy; Unit of measure: minutes (min); Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Sleep efficiency
Percentage of total sleep time (TST) divided by time in bed (TIB), derived from actigraphy; Unit of measure: percentage (%); Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Total sleep time (TST)
Total time spent asleep measured by actigraphy; Unit of measure: hours (h); Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Time in bed (TIB)
Total time in bed measured by actigraphy; Unit of measure: hours (h);
Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Number of awakenings after sleep onset
Number of awakenings after sleep onset measured by actigraphy; Unit of measure: count (n); Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Number of secondary sleep episodes after sleep onse
Number of additional sleep episodes after initial sleep onset measured by actigraphy; Unit of measure: count (n); ssessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Wake after sleep onset (WASO)
Minutes of wakefulness after sleep onset measured by actigraphy; Unit of measure: minutes (min); Assessment tool: ActTrust actigraph (Condor Instruments, Brazil)
Measured: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Maximal Expiratory Pressure (MEP)
Maximum expiratory pressure at the mouth during a maximal effort against occluded airway; Unit of measure: cmH₂O
Assessment tool: HOMED MVD300 digital manovacuometer
Measured: Assessment Before and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start11 Mar 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shirley nogueira de souza, Universidade Federal de Pernambuco
- Investigators
- Armele D de Andrade, PhD Pneumo, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149233
- Sponsor's protocol ID
- 7.330.179
- Other IDs
- CAAE: 84723724.2.0000.5208
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared upon reasonable request for academic and research purposes, following approval by the principal investigator and compliance with ethical standards. Participants' privacy and confidentiality will be strictly maintained
Publications
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.
PubMed 27296826
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inspiratory Muscle Training on Objective and Subjective Sleep Parameters in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07149233
- Acronym / sponsor ID
- 7.330.179
- Conditions
- Obstructive Sleep Apnea (OSA), Sleep
- Keywords
- Obstructive Sleep Apnea, Inspiratory Muscle Training, Objective and Subjective Sleep Parameters
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Inspiratory Muscle Training (IMT) | Experimental | Device: Inspiratory Muscle TrainingParticipants 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. |
| Group 2 - Sham Inspiratory Muscle Training | Sham comparator | Device: Inspiratory Muscle TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory 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 | Device | Group 1 - Inspiratory Muscle Training (IMT), Group 2 - Sham Inspiratory Muscle Training |
Primary outcome
sleep quality
Time frame: Sleep quality will be assessed before and after four weeks of inspiratory muscle training
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
daytime sleepiness
Time frame: Daytime sleepiness will be assessed before and after four weeks of inspiratory muscle training
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
19 secondary outcomes
hypoxic burden
Time frame: The hypoxic burden will be assessed before and after four weeks of inspiratory muscle training
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline, weekly during intervention (for load adjustment), and post-intervention (4 weeks)
Disease severity
Time frame: Disease severity will be assessed before and after four weeks of inspiratory muscle training.
Physical activity level
Time frame: Assessment Before and after 4 weeks
Respiratory endurance
Time frame: Assessment Before and after 4 weeks
Fatigue Index Strength
Time frame: Assessment Before and after 4 weeks
Peak inspiratory flow
Time frame: Assessment Before and after 4 weeks
Energy inspiratory
Time frame: Assessment Before and after 4 weeks
Volume inspiratory
Time frame: Assessment Before and after 4 weeks
Bedtime
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Wake-up time
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Sleep latency
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Sleep efficiency
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Total sleep time (TST)
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Time in bed (TIB)
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Number of awakenings after sleep onset
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Number of secondary sleep episodes after sleep onse
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Wake after sleep onset (WASO)
Time frame: 9 days before the start of IMT and 9 days after completion of the 4-week IMT protocol
Maximal Expiratory Pressure (MEP)
Time frame: Assessment Before and after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 27296826Aiello 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.
- Brazilian platform for research project submissionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared upon reasonable request for academic and research purposes, following approval by the principal investigator and compliance with ethical standards. Participants' privacy and confidentiality will be strictly maintained
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armele D de Andrade, PhD Pneumo study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Obstructive Sleep Apnea (OSA) and Sleep, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: Sleep quality will be assessed before and after four weeks of inspiratory muscle training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.