Effectiveness of Inspiratory Muscle Training on Objective and Subjective Sleep Parameters in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA), Sleep
Sponsor: Universidade Federal de Pernambuco

 
STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN AND 
INFORMED CONSENT FORM 
Version 1.0 | December 30, 2024 
 
 
Title of the Study: 
Efficacy of Inspiratory Muscle Training on Objective and Subjective Sleep 
Parameters in Apneic Patients: A Randomized Controlled Trial 
 
Principal Investigator: 
Shirley Nogueira de Souza 
Rua Porto União, 185, Afogados, Recife-PE, 50770-480 
Phone: +55 (81) 99674-2087 
Email: shirley.nsouza@ufpe.br 
Supervisors: 
Dr. Armele de Fátima Dornelas de Andrade – armele.andrade@ufpe.br 
Dr. Anna Myrna Jaguaribe de Lima – anna.myrna@ufrpe.br 
 
 
1. Background and Rationale 
 
Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder 
characterized by recurrent partial or complete collapse of the upper airway 
during sleep, associated with respiratory effort and oxygen desaturation. In 
OSA, sleep architecture is impaired because frequent awakenings during apnea 
episodes disrupt the sleep-wake cycle. This leads to poor sleep quality, excessive 
daytime sleepiness, and increased risk of cardiovascular complications. It is 
necessary to consider the complexity of OSA, its repercussions, and to seek 
treatment in an attempt to reduce the complications of this disease. Inspiratory 
Muscle Training (IMT) is a low-cost, non-invasive intervention that may 
strengthen respiratory muscles and improve breathing patterns during sleep. The 

search for therapies with proven effectiveness in treating OSA can improve 
clinical outcomes in this population. 
 
2. Objectives 
Primary Objective: 
 To evaluate the effectiveness of four weeks of IMT on objective and subjective 
sleep parameters in patients with OSA moderate to severe compared to a control 
group receiving IMT. 
Secondary Objectives: 
 Analyze the sleep pattern: total sleep time, number of nighttime awakenings, 
sleep efficiency, total time in bed, total awake time during sleep. 
 Evaluate sleep quality and excessive daytime sleepiness. 
 Analyze hypoxic burden during sleep. 
 
 
3. Study Design 
 
Study Type: Interventional (Clinical Trial) 
 
Allocation: Randomized 
 
Intervention Model: Parallel Assignment 
 
Masking: Triple-blind ( Investigator, Participant and Statistician) 
 
Primary Purpose: Treatment 
 
Estimated Enrollment: 30 participants 
 
Study Duration: 4 weeks 
 
4. Eligibility Criteria 
Inclusion Criteria: 
 Patients of both sexes; 
 Aged 18 to 70 years; 
 Diagnosis of moderate to severe OSA confirmed by polysomnography; 
 Not having started treatment for OSA. 

Exclusion Criteria: 
 Patients with neuromuscular, infectious, or immune diseases, tumors, or 
conditions that prevent IMT, manuvacuometry, or respiratory muscle tests; 
 Patients with unstable angina, untreated or uncontrolled high blood pressure, left 
heart dysfunction, brain aneurysm, or other heart problems that prevent 
respiratory muscle tests or IMT; 
 Deformities in the arms or hands that stop the use of actigraph or oximetry 
sensors; 
 Other sleep disorders like insomnia, hypoventilation syndrome, or needing 
continuous oxygen at home; 
 Cognitive impairments that make it hard to understand study procedures. 
 Starting or currently using CPAP treatment during the study week; 
 Attended pulmonary rehab within 6 months before the study; 
 Doing moderate or vigorous physical activities regularly in the last 30 days 
(according to IPAQ); 
 Using sleep medication for insomnia; 
 Having severe obesity; 
 Living in places with poor phone or internet access that prevent contact or data 
transmission from devices (actigraph or oximeter). 
 
5. Interventions 
Experimental Group: 
 
Inspiratory Muscle Training using Powerbreathe® Classic Light device 
 
Frequency: 2 times per day, 7 days per week, for 4 weeks 
 
Progressive load: 50%, 60%, and 75% of PIMax over four weeks 
Control Group: 
 
Same schedule using an unloaded device (no spring resistance) 
 
6. Outcome Measures 
Primary Outcomes: 
 
Sleep quality and  Severity of the disease.  
Secondary Outcomes: 

 
Epworth Sleepiness Scale (ESS) 
 
Pittsburgh Sleep Quality Index (PSQI) 
 
International Physical Activity Questionnaire (IPAQ) 
 
Respiratory muscle strength and endurance 
 
Sleep pattern (actigraphy) 
 
Hypoxic burden (Home polysomnography.) 
 
7. Study Procedures 
 
Screening of patient records and phone contact. 
 
Initial evaluation and informed consent 
 
Baseline measurements 
 
Randomization into intervention or control group 
 
4-week training protocol 
 
Post-intervention assessments 
 
Daily monitoring via telephone 
 
Sleep data collected for 9 days before and after training using wearable devices 
 
8. Data Collection and Management 
 
Data collected via validated questionnaires and electronic spreadsheets 
 
Sleep data extracted from actigraphy and oximetry equipment Home 
polysomnography) 
 
All information coded to protect participant confidentiality 
 
Data stored securely for a minimum of 5 years 
 
9. Statistical Analysis Plan 
 
Software: SPSS v26.0 
 
Normality tested using Shapiro-Wilk 
 
Two-way ANOVA for inter- and intra-group comparisons 
 
Tukey’s post-hoc test for subgroup analysis 
 
Significance level set at p < 0.05 
 
10. Ethical Considerations 

 
Approved by the Ethics Committee for Research Involving Human Beings at 
UFPE 
 
Informed Consent Form provided and signed prior to enrollment 
 
Participants may withdraw at any time without penalty 
 
All data treated confidentially and used exclusively for scientific purposes 
 
11. Monitoring and Safety 
 
Weekly in-person visits for training load adjustment 
 
Daily telephone follow-up 
 
Participants instructed to report any adverse effects 
 
Adverse events documented and managed by the study team 
 
12. Data Sharing Statement 
 
No personal or individual-level data will be publicly shared 
 
Aggregated study results may be published in scientific journals or conferences 
 
13. Study Location 
Sleep Outpatient Clinic 
Hospital Otavio de Freitas 
Recife – Pernambuco, Brazil 
 
14. Appendices 
 
Appendix A: Informed Consent Form 
 
Appendix B: Patient assessment 
 
Appendix C: Training Protocol Timeline 
 
Appendix D: Evaluation Questionnaires (ESS, PSQI, IPAQ,PGIC) 
 
Appendix E: Sleep Data Collection Forms (Actigraphy) 
 
 
 

 
 
 
INFORMED CONSENT FORM 
 
 
FEDERAL UNIVERSITY OF PERNAMBUCO 
CENTER FOR HEALTH SCIENCES 
DEPARTMENT OF PHYSIOTHERAPY 
GRADUATE PROGRAM IN PHYSIOTHERAPY 
 
INFORMED CONSENT FORM 
(FOR ADULTS OVER 18 YEARS OLD OR LEGALLY EMANCIPATED) 
You are invited to participate as a volunteer in the research study entitled: 
"Efficacy of Inspiratory Muscle Training on Objective and Subjective Sleep 
Parameters 
in 
Apneic 
Patients: 
A 
Randomized 
Controlled 
Trial," 
conducted by Shirley Nogueira de Souza, residing at Rua Porto União, 185, Afogados, 
Recife-PE, 
50770-480. 
Phone: (81) 99674-2087 — Email: shirley.nsouza@ufpe.br 
The study is supervised by Dr. Anna Myrna Jaguaribe de Lima (Phone: 81 99899-
0222, Email: anna.myrna@ufrpe.br) and co-supervised by Dr. Armele de Fátima 
Dornelas de Andrade (Phone: 81 98781-8965, Email: armele.andrade@ufpe.br). 
You are free to ask any questions you may have. Only after all your doubts have been 
clarified and you agree to participate, please initial each page and sign at the end of this 
document, in two copies—one for you and one for the principal investigator. 

Participation is entirely voluntary. You may refuse or withdraw at any stage without 
penalty or consequences 
RESEARCH INFORMATION 
JUSTIFICATION: 
Obstructive Sleep Apnea (OSA) negatively impacts general health and quality of life. It 
increases the risk of car and workplace accidents due to excessive sleepiness and is 
associated with serious conditions such as hypertension and heart disease. Treatment 
depends on severity, and low-cost, easy-to-use alternatives with proven efficacy may 
benefit individuals with moderate to severe OSA. 
OBJECTIVE: 
To evaluate the effectiveness of inspiratory muscle training on both objective and 
subjective sleep parameters in individuals with moderate to severe obstructive sleep 
apnea, compared to a control group. 
METHODOLOGY: 
This is an experimental clinical trial. Initially, patient records with previous sleep 
studies (polysomnography) will be reviewed. Those diagnosed with moderate to severe 
OSA will be contacted by phone and invited to participate. 
Participants who agree will attend an in-person visit at the Sleep Outpatient Clinic of 
Otavio de Freitas Hospital to sign this consent form and provide personal information. 
Participants will be randomly assigned to either the intervention or control group. 
Participants will receive a device and instructions to perform inspiratory muscle training 
twice a day, seven days a week, for four weeks. Device load will be adjusted weekly per 
protocol. A training diary will be provided for notes or adverse reactions. 
Sleep data will be collected using: 
 
Actigraphy device (worn like a wristwatch): worn 9 days before and 9 days 
after training, 24 hours/day except during bathing. 
 
Oxygen saturation sensor (portable oximeter): worn on the finger for one night 
after training. 

 
Type III portable home sleep monitoring (polysomnography): performed at 
home by the participant following instructions. 
Participants will also complete questionnaires before and after the 4-week program to 
assess: 
 
Daytime sleepiness 
 
Sleep quality 
 
Physical activity level 
Inspiratory muscle strength and performance will also be assessed using validated 
equipment. 
All sleep, oximetry, and polysomnography data will be downloaded, analyzed with 
specific software, and interpreted by trained professionals. 
After completing the protocol, participants will complete a questionnaire about 
perceived health changes and treatment satisfaction. 
RISKS: 
Potential risks include: 
 
Privacy breaches if health data were to be disclosed (mitigated by 
coded/anonymized records). 
 
Muscle fatigue or discomfort from training if improperly performed. 
 
Skin irritation or allergic reaction to the actigraphy, polysomnography, or 
oximeter devices. 
Precautions include: 
 
Instruction from a physiotherapist on proper equipment use and rest intervals. 
 
Daily phone support from the research team. 
 
Written records of any adverse events. 
If allergic reactions occur, participants may remove the device and seek medical or 
pharmaceutical care. Participants will be advised to adjust device fit to prevent 

discomfort. The research team is not responsible for medical treatment but will provide 
guidance. 
 
Access to a low-cost, easy-to-use alternative therapy. 
 
Strengthening of respiratory muscles, which may improve breathing, exercise 
tolerance, and reduce dyspnea. 
 
Potential benefit for those unable to access or tolerate CPAP. 
Participants in the control group will be offered the training after data collection if 
desired. 
All participants will receive an individual report with their results via email or 
WhatsApp. 
Participation is voluntary and refusal will not affect any services. Confidentiality will be 
strictly maintained. Results will only be disclosed in scientific forums or publications 
without personal identification. 
Data will be stored securely for a minimum of 5 years by the principal investigator. 
No fees or payments are involved. Compensation will be provided only in cases of 
proven harm related to participation, per judicial or extrajudicial decision. 
Transportation and meal costs will be reimbursed if needed. 
For 
ethical 
concerns, 
contact 
the 
UFPE 
Research 
Ethics 
Committee: 
Address: Avenida da Engenharia, s/n – 1st Floor, Room 4 – Cidade Universitária, 
Recife-PE, 
ZIP: 
50740-600 
Phone: (81) 2126-8588 — Email: cephumanos.ufpe@ufpe.br 
 
CONSENT TO PARTICIPATE AS A VOLUNTEER 
I, 
_____________________________________________, 
CPF: 
______________________, having read (or listened to a reading of) this document and 
had my questions answered by the investigator, freely consent to participate in the study 

entitled:"Efficacy of Inspiratory Muscle Training on Objective and Subjective 
Sleep Parameters in Apneic Patients: A Randomized Controlled Trial." 
I understand the procedures, risks, and benefits involved. I am aware I may withdraw 
my consent at any time without penalty or loss of care. 
 
Place and Date: ______________________________________ 
Participant’s Signature: ________________________________ 
Thumbprint (if applicable): 
 
 
We hereby confirm that consent was requested, explained, and accepted by the 
participant in our presence (two witnesses not affiliated with the research team): 
 
Name: ______________________________________ 
Signature: __________________________________  
Name: _______________________________________                                                                     
Signature: ____________________________________