Obstructive Sleep Apnea SyndromeNCT05210998
Respiratory Muscle Training Combined With Aerobic Exercise in Obstructive Sleep Apnea Syndrome
A study testing Gradual Aerobic exercise training AND Respiratory muscle training and Gradual Aerobic exercise training in people with Obstructive Sleep Apnea Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
In this study, which was planned to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in individuals with OSAS; 40 cases over the age of 40 who were diagnosed with severe (AHI: 30 and over) Obstructive Sleep Apnea Syndrome by polysomnography in the Sleep… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Gradual Aerobic exercise training AND Respiratory muscle training and Gradual Aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with Severe Obstructive Sleep Apnea
- Being over 40 years old
- Using CPAP
- Not to be included in any exercise and diet program throughout the study
Who cannot join
- Unstable angina pectoris,
- Body Mass Index (BMI)>35 kg/m2
- Chronic Lung Disease
- Neurological or musculoskeletal problems that prevent him from exercising
- Psychiatric disorder (eg, Bipolar disorder, schizophrenia)
- Unstable cardiovascular conditions
- Unstable metabolic conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty
Istanbul
About this study
Official title: Investigation of the Effects of Respiratory Muscle Training Combined With Aerobic Exercise in Persons With Obstructive Sleep Apnea Syndrome
In this study, which was planned to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in individuals with OSAS; 40 cases over the age of 40 who were diagnosed with severe (AHI: 30 and over) Obstructive Sleep Apnea Syndrome by polysomnography in the Sleep Laboratory of the Department of Chest Diseases of the Istanbul University Istanbul Medical Faculty Hospital will be included. The cases will be divided into two groups with the randomization system and the education of both groups will continue for a total of 8 weeks. In the literature, it is stated that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct therapy to CPAP or oral devices. No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. For this reason, OSAS patients using regular CPAP were planned as two groups in the treatment part of this study. Control Group: For gradual aerobic exercise training, bicycle ergometer training in the hospital environment and brisk walking at home once a week (3 days a week, 20-40 minutes a day) will be given under supervision two days a week.
Training Group: In addition to the aerobic exercise, the training group will be given respiratory muscle training once a day, 5 days a week, as a home program. Intraoral pressure measurements will be repeated once a week to calculate the new threshold load. Respiratory muscle training: Respiratory muscle training in 50% of MIP and 30% of MEP, as ICE + IME (5 days a week, 15 minutes per day, 15 minutes of IMI). Evaluations will be repeated before and after treatment. The original value of this study is that the effects of Respiratory Muscle Training Combined with Aerobic Exercise in addition to CPAP treatment will be investigated in individuals with OSAS.
Read the detailed description
Combined Exercises Grup: In addition to the aerobic exercise, the training group will be given respiratory muscle training once a day, 5 days a week, as a home program. Intraoral pressure measurements will be repeated once a week to calculate the new threshold load. Respiratory muscle training: Respiratory muscle training in 50% of MIP and 30% of MEP, as ICE + IME (5 days a week, 15 minutes per day, 15 minutes of IMI). Evaluations will be repeated before and after treatment. The original value of this study is that the effects of Respiratory Muscle Training Combined with Aerobic Exercise in addition to CPAP treatment will be investigated in individuals with OSAS.
Aerobic Exercises Grup: For gradual aerobic exercise training, bicycle ergometer training in the hospital environment and brisk walking at home once a week (3 days a week, 20-40 minutes a day) will be given under supervision two days a week Obstructive Sleep Apnea Syndrome (OSAS) is a syndrome with a highly complex pathophysiology characterized by repetitive complete or partial upper airway occlusions during sleep. As a result of collapse in the pharyngeal airways during sleep, air flow to the lungs decreases partially (hypopnea) or completely (apnea), hypoxia and hypercapnia develop, and the congestion ends with the end of sleep. The repetition of these situations that develop during sleep stimulates the sympathetic nervous system and causes changes in blood pressure.Excessive daytime sleepiness and neurocognitive disorders can be observed as a result of sleep disruptions and hypoxia that develop with multiple stimuli .It has been reported that there is a continuous increase in the prevalence of OSAS. The incidence of OSAS in the general adult population varies between 9-38%, with a higher incidence in males. Due to obesity, its prevalence is increasing at an alarming rate, especially in middle and high-income countries . OSAS causes potentially serious health consequences such as impaired quality of life, emotional impairment, neurocognitive impairment, permanent brain damage, cardiovascular morbidity, and sudden death during sleep. OSAS has a very complex pathophysiology and the roles of influencing factors are also variable among individuals. In the physiopathology of upper airway obstruction, factors such as anatomical and mechanical factors, impaired contractile function of upper airway muscles, respiratory control instability come to the fore . One of the mechanisms that cause altered neuromechanical responses in OSAS is the deterioration of the contractile function of the upper airway muscles. In these patients, the upper respiratory tract muscles work under hypoxic conditions and as a result, a modification in the muscle fiber structure develops. In this modification, muscle fibers change from type I fibers that are resistant to fatigue to type II muscle fibers that increase strength but are not resistant to fatigue. As a result, the contractility of the muscle is preserved, but the fatigue increases. With this modification in the muscle fiber, inflammation may occur in the muscle working under increased load, with muscle damage that impairs the contractility of the muscle. Muscle dysfunction may develop as a result of these events .
During sleep, there is a decrease in lung volume and upper airway dilator muscle tone. Therefore, upper and lower airway muscle function is relatively reduced during sleep and may increase airway obstruction. It is thought that increasing upper airway dilator muscle activity and increasing lung volume are effective in maintaining airway patency. Coordinated contraction of the upper airway dilator muscles (eg genioglossus) and inspiratory pump muscles (eg diaphragm) is required for breathing to continue with an open airway. Inspiratory muscle weakness increases susceptibility to hypoventilation during sleep .
Treatment methods of OSAS include conservative (Continuous Positive Airway Pressure (CPAP) device and intraoral device applications) and surgical interventions. CPAP therapy, which is the most effective method available in OSAS, has been shown to improve sleepiness, hypertension and many cardiovascular indices seen in patients . CPAP is considered the first choice in the treatment of especially moderate or severe OSAS cases, but it is costly and patient compliance is an important condition that affects treatment success.
It is known that respiratory muscle training increases respiratory muscle strength in people with COPD and neuromuscular diseases . It has been reported that inspiratory muscle training in OSAS patients improves OSAS severity, daytime sleepiness and sleep quality, decreases the severity and frequency of snoring, improves respiratory muscle strength, and can reduce the cost of CPAP treatment by increasing its use in rehabilitation programs. However, it has been shown that training applied to the upper respiratory tract with the didgeridoo instrument in people with snoring and OSAS reduces daytime sleepiness, apnea-hypopnea index, and upper airway collapse. Strengthening both inspiratory and expiratory muscles seems reasonable given that weakness of the upper airway and inspiratory muscles in these patients affects sleep-related outcome measures. In addition, it is stated in the literature that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct to CPAP or oral devices .
It is known that most of the patients with OSAS also have low exercise capacity. OSAS severity is associated with worsening exercise tolerance. In the treatment of OSAS patients, exercise training in addition to CPAP therapy has received increasing attention in recent years . It has been shown that regular exercise training applied in patients with OSAS reduces AHI, body weight and body mass index, improves aerobic capacity and quality of life . In a recent meta-analysis, aerobic exercise training has been reported to effectively improve quality of life, daytime sleepiness, and sleep quality . No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. The aim of this study is to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Gradual Aerobic exercise training AND Respiratory muscle training, Gradual Aerobic exercise training
- Keywords
- Sleep Apnea , Respiratory Muscle Training, Aerobic Exercise
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual Aerobic exercise training AND Respiratory muscle trainingOther
Combined Exercise Group
Gradual Aerobic exercise trainingOther
Aerobic exercise Group
| Study group | Role | What they receive |
|---|---|---|
| grup 1: | Active comparator | Combined Exercise Group:
Gradual aerobic exercise training AND Respiratory muscle training Receives: Other: Gradual Aerobic exercise training AND Respiratory muscle training |
| grup 2: | Active comparator | Aerobic Exercise Group:
Gradual Aerobic exercise training Receives: Other: Gradual Aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography (PSG)
Polysomnography is the gold standard diagnostic test for the diagnosis of adult patients with suspected OSAS based on a comprehensive sleep assessment. It is also used to evaluate the severity of OSAS and the effectiveness of treatment.Patients over the age of 40, who were diagnosed with severe (AHI: 30 and above) Obstructive Sleep Apnea Syndrome by a Chest Diseases Specialist by polysomnography in the Sleep Laboratory of the Chest Diseases Department of the Istanbul University Istanbul Medical Faculty Hospital, will be included in the study. Polysomnography is routinely performed in the Sleep Laboratory in the diagnosis and follow-up of patients with OSAS.
Measured: 8 weeks
Secondary outcomes (1)
Respiratory Muscle Strength Assessment.
In the evaluation of respiratory muscle strength, mouth pressure measurement method will be used in accordance with ATS/ERS criteria.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Seker Abanoz, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210998
- Sponsor's protocol ID
- Obstructive Sleep Apnea
- Status last verified
- Jun 2023
- First submitted
- 4 Dec 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eckert DJ, Malhotra A, Jordan AS. Mechanisms of apnea. Prog Cardiovasc Dis. 2009 Jan-Feb;51(4):313-23. doi: 10.1016/j.pcad.2008.02.003.
PubMed 19110133Hsia JC. Anatomy and physiology of the upper airway in obstructive sleep apnea. Operative Techniques in Otolaryngology-Head and Neck Surgery, 2015; 26(2):74-77
Wimms A, Woehrle H, Ketheeswaran S, Ramanan D, Armitstead J. Obstructive Sleep Apnea in Women: Specific Issues and Interventions. Biomed Res Int. 2016;2016:1764837. doi: 10.1155/2016/1764837. Epub 2016 Sep 6.
PubMed 27699167Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
PubMed 27568340Demir A, Ursavaş A, Aslan AT, Gülbay B, et al. Türk Toraks Derneği Obstrüktif Uyku Apne Sendromu Tanı Ve Tedavi Uzlaşı Raporu. Türk Toraks Dergisi 2012;13 EK 1 vol 13:5-9
Lacasse Y, Godbout C, Series F. Health-related quality of life in obstructive sleep apnoea. Eur Respir J. 2002 Mar;19(3):499-503. doi: 10.1183/09031936.02.00216902.
PubMed 11936529Vanek J, Prasko J, Genzor S, Ociskova M, Kantor K, Holubova M, Slepecky M, Nesnidal V, Kolek A, Sova M. Obstructive sleep apnea, depression and cognitive impairment. Sleep Med. 2020 Aug;72:50-58. doi: 10.1016/j.sleep.2020.03.017. Epub 2020 Mar 23.
PubMed 32544796Bradley TD, Floras JS. Obstructive sleep apnoea and its cardiovascular consequences. Lancet. 2009 Jan 3;373(9657):82-93. doi: 10.1016/S0140-6736(08)61622-0. Epub 2008 Dec 26.
PubMed 19101028Gami AS, Howard DE, Olson EJ, Somers VK. Day-night pattern of sudden death in obstructive sleep apnea. N Engl J Med. 2005 Mar 24;352(12):1206-14. doi: 10.1056/NEJMoa041832.
PubMed 15788497Jordan AS, White DP, Owens RL, Eckert DJ, Rahangdale S, Yim-Yeh S, Malhotra A. The effect of increased genioglossus activity and end-expiratory lung volume on pharyngeal collapse. J Appl Physiol (1985). 2010 Aug;109(2):469-75. doi: 10.1152/japplphysiol.00373.2010. Epub 2010 May 27.
PubMed 20507968Iftikhar IH, Bittencourt L, Youngstedt SD, Ayas N, Cistulli P, Schwab R, Durkin MW, Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary weight loss for sleep apnea: a network meta-analysis. Sleep Med. 2017 Feb;30:7-14. doi: 10.1016/j.sleep.2016.06.001. Epub 2016 Jun 28.
PubMed 28215266van Zeller M, Severo M, Santos AC, Drummond M. 5-years APAP adherence in OSA patients--do first impressions matter? Respir Med. 2013 Dec;107(12):2046-52. doi: 10.1016/j.rmed.2013.10.011. Epub 2013 Oct 16.
PubMed 24169074Donovan LM, Boeder S, Malhotra A, Patel SR. New developments in the use of positive airway pressure for obstructive sleep apnea. J Thorac Dis. 2015 Aug;7(8):1323-42. doi: 10.3978/j.issn.2072-1439.2015.07.30.
PubMed 26380760Geddes EL, O'Brien K, Reid WD, Brooks D, Crowe J. Inspiratory muscle training in adults with chronic obstructive pulmonary disease: an update of a systematic review. Respir Med. 2008 Dec;102(12):1715-29. doi: 10.1016/j.rmed.2008.07.005. Epub 2008 Aug 15.
PubMed 18708282Aslan GK, Gurses HN, Issever H, Kiyan E. Effects of respiratory muscle training on pulmonary functions in patients with slowly progressive neuromuscular disease: a randomized controlled trial. Clin Rehabil. 2014 Jun;28(6):573-81. doi: 10.1177/0269215513512215. Epub 2013 Nov 25.
PubMed 24275453
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Respiratory Muscle Training Combined With Aerobic Exercise in Persons With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05210998
- Acronym / sponsor ID
- Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Sleep Apnea , Respiratory Muscle Training, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 27 Jan 2022 (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.
In this study, which was planned to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in individuals with OSAS; 40 cases over the age of 40 who were diagnosed with severe (AHI: 30 and over) Obstructive Sleep Apnea Syndrome by polysomnography in the Sleep Laboratory of the Department of Chest Diseases of the Istanbul University Istanbul Medical Faculty Hospital will be included. The cases will be divided into two groups with the randomization system and the education of both groups will continue for a total of 8 weeks. In the literature, it is stated that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct therapy to CPAP or oral devices. No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. For this reason, OSAS patients using regular CPAP were planned as two groups in the treatment part of this study. Control Group: For gradual aerobic exercise training, bicycle ergometer training in the hospital environment and brisk walking at home once a week (3 days a week, 20-40 minutes a day) will be given under supervision two days a week.
Training Group: In addition to the aerobic exercise, the training group will be given respiratory muscle training once a day, 5 days a week, as a home program. Intraoral pressure measurements will be repeated once a week to calculate the new threshold load. Respiratory muscle training: Respiratory muscle training in 50% of MIP and 30% of MEP, as ICE + IME (5 days a week, 15 minutes per day, 15 minutes of IMI). Evaluations will be repeated before and after treatment. The original value of this study is that the effects of Respiratory Muscle Training Combined with Aerobic Exercise in addition to CPAP treatment will be investigated in individuals with OSAS.
Detailed description
Combined Exercises Grup: In addition to the aerobic exercise, the training group will be given respiratory muscle training once a day, 5 days a week, as a home program. Intraoral pressure measurements will be repeated once a week to calculate the new threshold load. Respiratory muscle training: Respiratory muscle training in 50% of MIP and 30% of MEP, as ICE + IME (5 days a week, 15 minutes per day, 15 minutes of IMI). Evaluations will be repeated before and after treatment. The original value of this study is that the effects of Respiratory Muscle Training Combined with Aerobic Exercise in addition to CPAP treatment will be investigated in individuals with OSAS.
Aerobic Exercises Grup: For gradual aerobic exercise training, bicycle ergometer training in the hospital environment and brisk walking at home once a week (3 days a week, 20-40 minutes a day) will be given under supervision two days a week Obstructive Sleep Apnea Syndrome (OSAS) is a syndrome with a highly complex pathophysiology characterized by repetitive complete or partial upper airway occlusions during sleep. As a result of collapse in the pharyngeal airways during sleep, air flow to the lungs decreases partially (hypopnea) or completely (apnea), hypoxia and hypercapnia develop, and the congestion ends with the end of sleep. The repetition of these situations that develop during sleep stimulates the sympathetic nervous system and causes changes in blood pressure.Excessive daytime sleepiness and neurocognitive disorders can be observed as a result of sleep disruptions and hypoxia that develop with multiple stimuli .It has been reported that there is a continuous increase in the prevalence of OSAS. The incidence of OSAS in the general adult population varies between 9-38%, with a higher incidence in males. Due to obesity, its prevalence is increasing at an alarming rate, especially in middle and high-income countries . OSAS causes potentially serious health consequences such as impaired quality of life, emotional impairment, neurocognitive impairment, permanent brain damage, cardiovascular morbidity, and sudden death during sleep. OSAS has a very complex pathophysiology and the roles of influencing factors are also variable among individuals. In the physiopathology of upper airway obstruction, factors such as anatomical and mechanical factors, impaired contractile function of upper airway muscles, respiratory control instability come to the fore . One of the mechanisms that cause altered neuromechanical responses in OSAS is the deterioration of the contractile function of the upper airway muscles. In these patients, the upper respiratory tract muscles work under hypoxic conditions and as a result, a modification in the muscle fiber structure develops. In this modification, muscle fibers change from type I fibers that are resistant to fatigue to type II muscle fibers that increase strength but are not resistant to fatigue. As a result, the contractility of the muscle is preserved, but the fatigue increases. With this modification in the muscle fiber, inflammation may occur in the muscle working under increased load, with muscle damage that impairs the contractility of the muscle. Muscle dysfunction may develop as a result of these events .
During sleep, there is a decrease in lung volume and upper airway dilator muscle tone. Therefore, upper and lower airway muscle function is relatively reduced during sleep and may increase airway obstruction. It is thought that increasing upper airway dilator muscle activity and increasing lung volume are effective in maintaining airway patency. Coordinated contraction of the upper airway dilator muscles (eg genioglossus) and inspiratory pump muscles (eg diaphragm) is required for breathing to continue with an open airway. Inspiratory muscle weakness increases susceptibility to hypoventilation during sleep .
Treatment methods of OSAS include conservative (Continuous Positive Airway Pressure (CPAP) device and intraoral device applications) and surgical interventions. CPAP therapy, which is the most effective method available in OSAS, has been shown to improve sleepiness, hypertension and many cardiovascular indices seen in patients . CPAP is considered the first choice in the treatment of especially moderate or severe OSAS cases, but it is costly and patient compliance is an important condition that affects treatment success.
It is known that respiratory muscle training increases respiratory muscle strength in people with COPD and neuromuscular diseases . It has been reported that inspiratory muscle training in OSAS patients improves OSAS severity, daytime sleepiness and sleep quality, decreases the severity and frequency of snoring, improves respiratory muscle strength, and can reduce the cost of CPAP treatment by increasing its use in rehabilitation programs. However, it has been shown that training applied to the upper respiratory tract with the didgeridoo instrument in people with snoring and OSAS reduces daytime sleepiness, apnea-hypopnea index, and upper airway collapse. Strengthening both inspiratory and expiratory muscles seems reasonable given that weakness of the upper airway and inspiratory muscles in these patients affects sleep-related outcome measures. In addition, it is stated in the literature that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct to CPAP or oral devices .
It is known that most of the patients with OSAS also have low exercise capacity. OSAS severity is associated with worsening exercise tolerance. In the treatment of OSAS patients, exercise training in addition to CPAP therapy has received increasing attention in recent years . It has been shown that regular exercise training applied in patients with OSAS reduces AHI, body weight and body mass index, improves aerobic capacity and quality of life . In a recent meta-analysis, aerobic exercise training has been reported to effectively improve quality of life, daytime sleepiness, and sleep quality . No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. The aim of this study is to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grup 1: | Active comparator | Other: Gradual Aerobic exercise training AND Respiratory muscle trainingCombined Exercise Group: Gradual aerobic exercise training AND Respiratory muscle training |
| grup 2: | Active comparator | Other: Gradual Aerobic exercise trainingAerobic Exercise Group: Gradual Aerobic exercise training |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with Severe Obstructive Sleep Apnea
- Being over 40 years old
- Using CPAP
- Not to be included in any exercise and diet program throughout the study
Key exclusion criteria (7 listed)
- Unstable angina pectoris,
- Body Mass Index (BMI)>35 kg/m2
- Chronic Lung Disease
- Neurological or musculoskeletal problems that prevent him from exercising
- Psychiatric disorder (eg, Bipolar disorder, schizophrenia)
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 |
|---|---|---|
| Gradual Aerobic exercise training AND Respiratory muscle trainingCombined Exercise Group | Other | grup 1: |
| Gradual Aerobic exercise trainingAerobic exercise Group | Other | grup 2: |
Primary outcome
Polysomnography (PSG)
Time frame: 8 weeks
Polysomnography is the gold standard diagnostic test for the diagnosis of adult patients with suspected OSAS based on a comprehensive sleep assessment. It is also used to evaluate the severity of OSAS and the effectiveness of treatment.Patients over the age of 40, who were diagnosed with severe (AHI: 30 and above) Obstructive Sleep Apnea Syndrome by a Chest Diseases Specialist by polysomnography in the Sleep Laboratory of the Chest Diseases Department of the Istanbul University Istanbul Medical Faculty Hospital, will be included in the study. Polysomnography is routinely performed in the Sleep Laboratory in the diagnosis and follow-up of patients with OSAS.
1 secondary outcome
Respiratory Muscle Strength Assessment.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 19110133Eckert DJ, Malhotra A, Jordan AS. Mechanisms of apnea. Prog Cardiovasc Dis. 2009 Jan-Feb;51(4):313-23. doi: 10.1016/j.pcad.2008.02.003.
- BackgroundHsia JC. Anatomy and physiology of the upper airway in obstructive sleep apnea. Operative Techniques in Otolaryngology-Head and Neck Surgery, 2015; 26(2):74-77
- Background: PubMed 27699167Wimms A, Woehrle H, Ketheeswaran S, Ramanan D, Armitstead J. Obstructive Sleep Apnea in Women: Specific Issues and Interventions. Biomed Res Int. 2016;2016:1764837. doi: 10.1155/2016/1764837. Epub 2016 Sep 6.
- Background: PubMed 27568340Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
- BackgroundDemir A, Ursavaş A, Aslan AT, Gülbay B, et al. Türk Toraks Derneği Obstrüktif Uyku Apne Sendromu Tanı Ve Tedavi Uzlaşı Raporu. Türk Toraks Dergisi 2012;13 EK 1 vol 13:5-9
- Background: PubMed 11936529Lacasse Y, Godbout C, Series F. Health-related quality of life in obstructive sleep apnoea. Eur Respir J. 2002 Mar;19(3):499-503. doi: 10.1183/09031936.02.00216902.
- Background: PubMed 32544796Vanek J, Prasko J, Genzor S, Ociskova M, Kantor K, Holubova M, Slepecky M, Nesnidal V, Kolek A, Sova M. Obstructive sleep apnea, depression and cognitive impairment. Sleep Med. 2020 Aug;72:50-58. doi: 10.1016/j.sleep.2020.03.017. Epub 2020 Mar 23.
- Background: PubMed 19101028Bradley TD, Floras JS. Obstructive sleep apnoea and its cardiovascular consequences. Lancet. 2009 Jan 3;373(9657):82-93. doi: 10.1016/S0140-6736(08)61622-0. Epub 2008 Dec 26.
- Background: PubMed 15788497Gami AS, Howard DE, Olson EJ, Somers VK. Day-night pattern of sudden death in obstructive sleep apnea. N Engl J Med. 2005 Mar 24;352(12):1206-14. doi: 10.1056/NEJMoa041832.
- Background: PubMed 20507968Jordan AS, White DP, Owens RL, Eckert DJ, Rahangdale S, Yim-Yeh S, Malhotra A. The effect of increased genioglossus activity and end-expiratory lung volume on pharyngeal collapse. J Appl Physiol (1985). 2010 Aug;109(2):469-75. doi: 10.1152/japplphysiol.00373.2010. Epub 2010 May 27.
- Background: PubMed 28215266Iftikhar IH, Bittencourt L, Youngstedt SD, Ayas N, Cistulli P, Schwab R, Durkin MW, Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary weight loss for sleep apnea: a network meta-analysis. Sleep Med. 2017 Feb;30:7-14. doi: 10.1016/j.sleep.2016.06.001. Epub 2016 Jun 28.
- Background: PubMed 24169074van Zeller M, Severo M, Santos AC, Drummond M. 5-years APAP adherence in OSA patients--do first impressions matter? Respir Med. 2013 Dec;107(12):2046-52. doi: 10.1016/j.rmed.2013.10.011. Epub 2013 Oct 16.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual Aerobic exercise training AND Respiratory muscle training and Gradual Aerobic exercise training in people with Obstructive Sleep Apnea Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 7 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: finished, as of the sponsor's last update on 15 Feb 2024. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Polysomnography (PSG) (time frame: 8 weeks). 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 NCT05210998, which also lists 24 linked publications.
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 15 Feb 2024.