Obstructive Sleep ApneaNCT06087900

Effect of Different Exercise Modalities Training in Patients With Obstructive Sleep Apnea.

A study testing Moderate continuous training (MICT), High intensity interval training (HIIT) and Inspiratory muscle training (IMT) in people with Obstructive Sleep Apnea, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study was to compare different exercise modalities (moderate continuous intensity training, high intensity interval training, and inspiratory muscle training) on Apnea-Hypopnea index and oxidative stress in patients with Obstructive sleep apnea. Read more about this study

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Moderate continuous training (MICT), High intensity interval training (HIIT) and Inspiratory muscle training (IMT)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteThailand
Study dates: 1 Aug 2022to 9 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 20 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diagnosed with mild (AHI 5-15) or moderate (AHI 15-30) OSA, aged between 20 - 50 years.
BMI between 18.5 - 24.9 kg/ m2.
No history of exercise more than 150 min/week for 4 weeks.
No used CPAP or discontinue at least 2 weeks.
No history for surgery for OSA treatment. Screened by physician that patients have not had Uncontrolled diabetes (blood sugar 180 mg/dL) Uncontrolled hypertension (BP 139/89 mmHg) Any coronary artery disease Any neuromuscular disease Chronic Obstructive Pulmonary Disease; COPD Any cognitive disease Other sleep-related disorders Cancer
7. Not a person with current smoker, menopause or pregnancy. 8. Stable medication. 9. Willing to participate in this research.

Who cannot join

Cannot participate at least 80% of exercise program.
Inevitable event (injury, sickness, etc.)
Unwilling to continue this research.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Faculty of Sports Science, Chulalongkorn University
Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

Official title: Effects of Different Exercise Modalities on Apnea-Hypopnea Index and Oxidative Stress in Patients With Obstructive Sleep Apnea.

Read the detailed description

Forty patients with OSA aged 20 and 50 years old, dividing into 4 groups (MICT, HIIT, IMT, and CON) by stratified (with sex, age, and OSA severity) and single random sampling. The MICT group received 50 minutes of running at 65-70% of maximum heart rate 3 days/week for 12 weeks. The HIIT groups received 28 minutes of running (High intensity at 85-90% of maximum heart rate 2 minutes interval with low intensity 50-55% of maximum heart rate 2 minutes) 3 days/week for 12 weeks. The IMT group received Powerbreathe ® device, performing 240 breath (8 sets) per day at 50% of Maximal inspiratory pressure (MIP), 5 days/week for 12 week. The CON group did not have any intervention but usual care. Data collection was split 2 days (1st day for polysomnography evaluation, and 2nd day for questionnaire, blood collection, body composition, exhaled nitric oxide, pulmonary function, respiratory muscle strength and aerobic capacity). All variables were measured before and after exercise program.

Conditions: Obstructive Sleep Apnea
Being tested: Moderate continuous training (MICT), High intensity interval training (HIIT), Inspiratory muscle training (IMT), Control
Keywords: HIIT, Pulmonary function, Sleep, Exercise, Polysomnography
Medical subject headings: Sleep Apnea, Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moderate continuous training (MICT)Other
The participants received a moderate continuous training (MICT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 50 minutes of exercise at 65-70% of maximal heart rate, and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise increases to 70-75% of maximal heart rate at week 7-12.
High intensity interval training (HIIT)Other
The participants received a 7x2 high intensity interval training (HIIT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 28 minutes of exercise (2 minutes of high intensity at 85-90% of maximal heart rate interval with 2 minutes of low intensity at 50-55% of maximal heart rate 7 times), and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise at high intensity increases to 90-95% of maximal heart rate at week 7-12.
Inspiratory muscle training (IMT)Other
The participants received Powerbreathe ® ClassicLight in this training program. The IMT group demonstrated the training 8 cycles of 30 breath, 5 days/week with progressive load 50% of maximal inspiratory pressure (MIP) at week 1-3, 60% of MIP at week 4-6, 70% of MIP at week 7-9, and 80% of MIP at week 10-12. Every first day of the week participants had to undergoing load adjustment at laboratory
ControlOther
The CON group did not have any intervention but usual care.

Study groups in NCT06087900
Study group	Role	What they receive
Moderate continuous training (MICT)	Experimental	The participants received a moderate continuous training (MICT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 50 minutes of exercise at 65-70% of maximal heart rate, and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise increases to 70-75% of maximal heart rate at week 7-12. Receives: Other: Moderate continuous training (MICT)
High intensity interval training (HIIT)	Experimental	The participants received a 7x2 high intensity interval training (HIIT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 28 minutes of exercise (2 minutes of high intensity at 85-90% of maximal heart rate interval with 2 minutes of low intensity at 50-55% of maximal heart rate 7 times), and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise at high intensity increases to 90-95% of maximal heart rate at week 7-12. Receives: Other: High intensity interval training (HIIT)
Inspiratory muscle training (IMT)	Experimental	The participants received Powerbreathe ® ClassicLight in this training program. The IMT group demonstrated the training 8 cycles of 30 breath, 5 days/week with progressive load 50% of maximal inspiratory pressure (MIP) at week 1-3, 60% of MIP at week 4-6, 70% of MIP at week 7-9, and 80% of MIP at week 10-12. Every first day of the week participants had to undergoing load adjustment at laboratory Receives: Other: Inspiratory muscle training (IMT)
Control	Sham comparator	The CON group did not have any intervention but usual care. Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Apnea-Hypopnea index (event/hr)
The study performed polysomnography in the sleep laboratory using standard EEG with frontal leads (F1, F2), central leads (C3, C4), occipital leads (O1, O2), and reference leads at mastoids (M1, M2). Electromyography and electrooculography were also used. Oxygen saturation (SpO2) was measured using a finger probe. Air flow was measured using two methods: a nasal pressure transducer and an oral-nasal thermocouple. Respiratory movements of the thorax and abdomen were monitored using respiratory inductance plethysmography. The position of the body was measured using a position sensor attached to the anterior chest wall on the thoracic belt.
Measured: Change from Baseline Apnea-Hypopnea index at 12 weeks.
Oxidative stress
Blood was collected into sterile ethylenediaminetetraacetic acid (EDTA) tubes from the cubital vein by a nurse at Exercise Physiology laboratory, Chulalongkorn University. The collected blood was analyzed by a medical technologist. To obtain plasma, the EDTA blood samples were centrifuged at 3,000 rpm for 10 minutes. All plasma samples were stored at a temperature of -80°C until they were used for various assays.
Measured: Change from Baseline Oxidative stress at 12 weeks.
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) Thai version was evaluated at baseline and post-intervention to assess subjective sleep quality over the previous 2 weeks. This index aimed to evaluate their subjective sleep quality over the preceding two weeks. The PSQI provided seven component scores, which included assessments of sleep quality, the time taken to fall asleep, the duration of sleep, the regularity of sleep, disturbances during sleep, the use of sleep medications, and daytime dysfunction. By summing up the scores from these subscales, a global score ranging from 0 to 21 was calculated. A global score above 5 is generally considered an indication of poor sleep quality.
Measured: Change from Baseline Sleep-related and Quality of Life by The Pittsburgh Sleep Quality Index (PSQI) questionnaire at 12 weeks.
The Short Form-36 (SF-36) questionnaire
The Short Form-36 (SF-36) questionnaire Thai version was evaluated at baseline and post-intervention. This questionnaire consists of 36 questions that are used to assess quality of life (QoL) across eight domains related to both physical and mental health. These domains include physical functioning, role limitations due to physical health (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional health (role-emotional), and mental health. Each domain is scored on a scale of 0 to 100, where higher scores indicate a better health-related quality of life (HRQL) compared to lower scores.
Measured: Change from Baseline Sleep-related and Quality of Life by The The Short Form-36 (SF-36) questionnaire at 12 weeks.
The Functional Outcomes of Sleep Questionnaire (FOSQ)
The Functional Outcomes of Sleep Questionnaire (FOSQ) Thai version was evaluated at baseline and post-intervention. This questionnaire specifically designed to assess health-related quality of life in relation to sleep disorders. It comprises 30 items that examine five domains related to normal daily life: general productivity (8 items), vigilance (7 items), social outcome (2 items), activity level (9 items), and sexual relationship (4 items). Each subscale and a global score were calculated, with the subscale scores ranging from 1 to 4 and the global score ranging from 5 to 20. A lower score indicates a higher level of dysfunction or poorer quality of life.
Measured: Change from Baseline Sleep-related and Quality of Life by The Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 weeks.
The Epworth sleepiness scale (ESS)
The Epworth sleepiness scale (ESS) Thai version was evaluated at baseline and post-intervention. This questionnaire is used to assess excessive daytime sleepiness (EDS). The questionnaire consists of eight scenarios where individuals rate their potential for dozing off or falling asleep on a scale of 0 to 3. The ESS has demonstrated excellent internal consistency and test-retest reliability, making it suitable for assessing the effectiveness of interventions. A total ESS score greater than 10 indicates the presence of EDS and a high risk of sleep-related breathing disorders.
Measured: Change from Baseline Sleep-related and Quality of Life by The Epworth sleepiness scale (ESS) Questionnaire at 12 weeks.

Secondary outcomes (9)

Pulmonary function (Forced vital capacity; FVC)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FVC will be reported in liter (L).
Measured: Change from baseline FVC at 12 weeks.
Pulmonary function (Forced Expiratory Volume in one second; FEV1)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1 (L) will be reported in liter (L).
Measured: Change from baseline FEV1 at 12 weeks.
Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1/FVC will be reported in percent (%).
Measured: Change from baseline FEV1/FVC at 12 weeks.
Pulmonary function (Peak expiratory flow; PEF)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. PEF will be reported in liter per minute (L/min).
Measured: Change from baseline PEF at 12 weeks.
Pulmonary function (Forced expiratory flow at 25 - 75% of FVC; FEF25-75%)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEF25-75% will be reported in liter per second (L/sec).
Measured: Change from baseline FEF25-75% at 12 weeks.
Pulmonary function (Maximal voluntary ventilation; MVV)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). During the MVV maneuver, participants were instructed to demonstrate in rapid and forceful inhalation and exhalation for a duration of 10 seconds. MVV will be reported in liter per minute (L/min).
Measured: Change from baseline MVV at 12 weeks.
Respiratory muscle strength
Respiratory muscle strength was evaluated by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in centimeters of water (cmH2O). The participants were seated and utilized a portable handheld mouth pressure meter (MicroRPM), along with a nose clip. To assess MIP, participants were instructed to exhale until they emptied their lungs at the point of functional residual capacity (FRC). Participants held the device to their mouth and forcefully inhaled for 1-2 seconds. For the measurement of MEP, participants were directed to inhale until their lungs were completely filled with air, starting from the total lung capacity (TLC) point. Participants were asked to maintain the device on their mouth and forcefully exhaled for 1-2 seconds.
Measured: Change from baseline Respiratory muscle strength at 12 weeks.
Exhaled nitric oxide (ppb)
The participants were instructed to sit upright and hold the device (NObreath, BedFont, UK). They were asked to take a deep breath and fill their lungs completely, and then exhale through the mouthpiece while ensuring that the ball in the flow indicator remained in the middle of the white band. The exhalation time was set at 12 seconds. Each participant was requested to repeat the measurement three times.
Measured: Change from baseline Exhaled nitric oxide at 12 weeks.
Aerobic capacity (ml/kg/min)
Participants were prepared for a 4-lead electrocardiogram before undergoing exercise tests on a treadmill equipped with a gas analyzer. The protocol began at an intensity of approximately 2 METs and involved increments in speed and/or grade every 20 seconds, equivalent to 0.3 METs. During the last 20 seconds of each 3-minute segment, the speed and grade settings matched those of the standard Bruce protocol (e.g., 3 minutes: 1.7 mph, 10% grade). Heart rate measurements were taken during the last 5 seconds of every minute and at peak exercise. Participants were asked to rate their perceived exertion during the last 5 seconds of each minute and immediately after the test (peak rating of perceived exertion). Blood pressure was measured during the last 30 seconds of minutes 3, 6, 9, and 11, as well as immediately after the test.
Measured: Change from baseline Aerobic capacity at 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20229 Jul 2023

First posted18 Oct 2023
Study start1 Aug 2022
Primary completion1 Nov 2022
Study completion9 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06087900
Sponsor's protocol ID: EX PHYSIO SPSC 8
Status last verified: Sep 2023
First submitted: 15 Sep 2023
Last updated: 18 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Karlsen T, Nes BM, Tjonna AE, Engstrom M, Stoylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport Exerc Med. 2017 Feb 8;2(1):bmjsem-2016-000155. doi: 10.1136/bmjsem-2016-000155. eCollection 2016.
PubMed 29616142
Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.
PubMed 22131599
Nobrega-Junior JCN, Dornelas de Andrade A, de Andrade EAM, Andrade MDA, Ribeiro ASV, Pedrosa RP, Ferreira APL, de Lima AMJ. Inspiratory Muscle Training in the Severity of Obstructive Sleep Apnea, Sleep Quality and Excessive Daytime Sleepiness: A Placebo-Controlled, Randomized Trial. Nat Sci Sleep. 2020 Dec 2;12:1105-1113. doi: 10.2147/NSS.S269360. eCollection 2020.
PubMed 33293881
Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156.
PubMed 28117479
Krittayaphong R, Bhuripanyo K, Raungratanaamporn O, Chotinaiwatarakul C, Chaowalit N, Punlee K, Kangkagate C, Chaithiraphan S. Reliability of Thai version of SF-36 questionnaire for the evaluation of quality of life in cardiac patients. J Med Assoc Thai. 2000 Nov;83 Suppl 2:S130-6.
PubMed 11194004

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Different Exercise Modalities on Apnea-Hypopnea Index and Oxidative Stress in Patients With Obstructive Sleep Apnea.
ClinicalTrials.gov ID: NCT06087900
Acronym / sponsor ID: EX PHYSIO SPSC 8
Conditions: Obstructive Sleep Apnea
Keywords: HIIT, Pulmonary function, Sleep, Exercise, Polysomnography
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 1 Nov 2022 (actual)
Study completion: 9 Jul 2023 (actual)
First posted: 18 Oct 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Moderate continuous training (MICT)	Experimental	Other: Moderate continuous training (MICT)The participants received a moderate continuous training (MICT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 50 minutes of exercise at 65-70% of maximal heart rate, and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise increases to 70-75% of maximal heart rate at week 7-12.
High intensity interval training (HIIT)	Experimental	Other: High intensity interval training (HIIT)The participants received a 7x2 high intensity interval training (HIIT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 28 minutes of exercise (2 minutes of high intensity at 85-90% of maximal heart rate interval with 2 minutes of low intensity at 50-55% of maximal heart rate 7 times), and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise at high intensity increases to 90-95% of maximal heart rate at week 7-12.
Inspiratory muscle training (IMT)	Experimental	Other: Inspiratory muscle training (IMT)The participants received Powerbreathe ® ClassicLight in this training program. The IMT group demonstrated the training 8 cycles of 30 breath, 5 days/week with progressive load 50% of maximal inspiratory pressure (MIP) at week 1-3, 60% of MIP at week 4-6, 70% of MIP at week 7-9, and 80% of MIP at week 10-12. Every first day of the week participants had to undergoing load adjustment at laboratory
Control	Sham comparator	Other: ControlThe CON group did not have any intervention but usual care.

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Diagnosed with mild (AHI 5-15) or moderate (AHI 15-30) OSA, aged between 20 - 50 years.
BMI between 18.5 - 24.9 kg/ m2.
No history of exercise more than 150 min/week for 4 weeks.
No used CPAP or discontinue at least 2 weeks.
No history for surgery for OSA treatment. Screened by physician that patients have not had Uncontrolled diabetes (blood sugar 180 mg/dL) Uncontrolled hypertension (BP 139/89 mmHg) Any coronary artery disease Any neuromuscular disease Chronic Obstructive Pulmonary Disease; COPD Any cognitive disease Other sleep-related disorders Cancer

Key exclusion criteria (3 listed)

Cannot participate at least 80% of exercise program.
Inevitable event (injury, sickness, etc.)
Unwilling to continue this research.

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
Moderate continuous training (MICT)The participants received a moderate continuous training (MICT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 50 minutes of exercise at 65-70% of maximal heart rate, and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise increases to 70-75% of maximal heart rate at week 7-12.	Other	Moderate continuous training (MICT)
High intensity interval training (HIIT)The participants received a 7x2 high intensity interval training (HIIT) program of walking or running a treadmill 3 days/week, 12 weeks. This training comprises training comprises 5 minutes of warm up at 50-55% of maximal heart rate, following by 28 minutes of exercise (2 minutes of high intensity at 85-90% of maximal heart rate interval with 2 minutes of low intensity at 50-55% of maximal heart rate 7 times), and 5 minutes of cool down at 50-55% of maximal heart rate. The intensity of exercise at high intensity increases to 90-95% of maximal heart rate at week 7-12.	Other	High intensity interval training (HIIT)
Inspiratory muscle training (IMT)The participants received Powerbreathe ® ClassicLight in this training program. The IMT group demonstrated the training 8 cycles of 30 breath, 5 days/week with progressive load 50% of maximal inspiratory pressure (MIP) at week 1-3, 60% of MIP at week 4-6, 70% of MIP at week 7-9, and 80% of MIP at week 10-12. Every first day of the week participants had to undergoing load adjustment at laboratory	Other	Inspiratory muscle training (IMT)
ControlThe CON group did not have any intervention but usual care.	Other	Control

Primary outcome

Apnea-Hypopnea index (event/hr)
Time frame: Change from Baseline Apnea-Hypopnea index at 12 weeks.
The study performed polysomnography in the sleep laboratory using standard EEG with frontal leads (F1, F2), central leads (C3, C4), occipital leads (O1, O2), and reference leads at mastoids (M1, M2). Electromyography and electrooculography were also used. Oxygen saturation (SpO2) was measured using a finger probe. Air flow was measured using two methods: a nasal pressure transducer and an oral-nasal thermocouple. Respiratory movements of the thorax and abdomen were monitored using respiratory inductance plethysmography. The position of the body was measured using a position sensor attached to the anterior chest wall on the thoracic belt.
Oxidative stress
Time frame: Change from Baseline Oxidative stress at 12 weeks.
Blood was collected into sterile ethylenediaminetetraacetic acid (EDTA) tubes from the cubital vein by a nurse at Exercise Physiology laboratory, Chulalongkorn University. The collected blood was analyzed by a medical technologist. To obtain plasma, the EDTA blood samples were centrifuged at 3,000 rpm for 10 minutes. All plasma samples were stored at a temperature of -80°C until they were used for various assays.
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from Baseline Sleep-related and Quality of Life by The Pittsburgh Sleep Quality Index (PSQI) questionnaire at 12 weeks.
The Pittsburgh Sleep Quality Index (PSQI) Thai version was evaluated at baseline and post-intervention to assess subjective sleep quality over the previous 2 weeks. This index aimed to evaluate their subjective sleep quality over the preceding two weeks. The PSQI provided seven component scores, which included assessments of sleep quality, the time taken to fall asleep, the duration of sleep, the regularity of sleep, disturbances during sleep, the use of sleep medications, and daytime dysfunction. By summing up the scores from these subscales, a global score ranging from 0 to 21 was calculated. A global score above 5 is generally considered an indication of poor sleep quality.
The Short Form-36 (SF-36) questionnaire
Time frame: Change from Baseline Sleep-related and Quality of Life by The The Short Form-36 (SF-36) questionnaire at 12 weeks.
The Short Form-36 (SF-36) questionnaire Thai version was evaluated at baseline and post-intervention. This questionnaire consists of 36 questions that are used to assess quality of life (QoL) across eight domains related to both physical and mental health. These domains include physical functioning, role limitations due to physical health (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional health (role-emotional), and mental health. Each domain is scored on a scale of 0 to 100, where higher scores indicate a better health-related quality of life (HRQL) compared to lower scores.
The Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: Change from Baseline Sleep-related and Quality of Life by The Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 weeks.
The Functional Outcomes of Sleep Questionnaire (FOSQ) Thai version was evaluated at baseline and post-intervention. This questionnaire specifically designed to assess health-related quality of life in relation to sleep disorders. It comprises 30 items that examine five domains related to normal daily life: general productivity (8 items), vigilance (7 items), social outcome (2 items), activity level (9 items), and sexual relationship (4 items). Each subscale and a global score were calculated, with the subscale scores ranging from 1 to 4 and the global score ranging from 5 to 20. A lower score indicates a higher level of dysfunction or poorer quality of life.
The Epworth sleepiness scale (ESS)
Time frame: Change from Baseline Sleep-related and Quality of Life by The Epworth sleepiness scale (ESS) Questionnaire at 12 weeks.
The Epworth sleepiness scale (ESS) Thai version was evaluated at baseline and post-intervention. This questionnaire is used to assess excessive daytime sleepiness (EDS). The questionnaire consists of eight scenarios where individuals rate their potential for dozing off or falling asleep on a scale of 0 to 3. The ESS has demonstrated excellent internal consistency and test-retest reliability, making it suitable for assessing the effectiveness of interventions. A total ESS score greater than 10 indicates the presence of EDS and a high risk of sleep-related breathing disorders.

9 secondary outcomes

Pulmonary function (Forced vital capacity; FVC)
Time frame: Change from baseline FVC at 12 weeks.
Pulmonary function (Forced Expiratory Volume in one second; FEV1)
Time frame: Change from baseline FEV1 at 12 weeks.
Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)
Time frame: Change from baseline FEV1/FVC at 12 weeks.
Pulmonary function (Peak expiratory flow; PEF)
Time frame: Change from baseline PEF at 12 weeks.
Pulmonary function (Forced expiratory flow at 25 - 75% of FVC; FEF25-75%)
Time frame: Change from baseline FEF25-75% at 12 weeks.
Pulmonary function (Maximal voluntary ventilation; MVV)
Time frame: Change from baseline MVV at 12 weeks.
Respiratory muscle strength
Time frame: Change from baseline Respiratory muscle strength at 12 weeks.
Exhaled nitric oxide (ppb)
Time frame: Change from baseline Exhaled nitric oxide at 12 weeks.
Aerobic capacity (ml/kg/min)
Time frame: Change from baseline Aerobic capacity at 12 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 18 Oct 2023.
Results publication: PubMed 29616142Karlsen T, Nes BM, Tjonna AE, Engstrom M, Stoylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport Exerc Med. 2017 Feb 8;2(1):bmjsem-2016-000155. doi: 10.1136/bmjsem-2016-000155. eCollection 2016.
Results publication: PubMed 22131599Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.
Results publication: PubMed 33293881Nobrega-Junior JCN, Dornelas de Andrade A, de Andrade EAM, Andrade MDA, Ribeiro ASV, Pedrosa RP, Ferreira APL, de Lima AMJ. Inspiratory Muscle Training in the Severity of Obstructive Sleep Apnea, Sleep Quality and Excessive Daytime Sleepiness: A Placebo-Controlled, Randomized Trial. Nat Sci Sleep. 2020 Dec 2;12:1105-1113. doi: 10.2147/NSS.S269360. eCollection 2020.
Results publication: PubMed 28117479Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156.
Results publication: PubMed 11194004Krittayaphong R, Bhuripanyo K, Raungratanaamporn O, Chotinaiwatarakul C, Chaowalit N, Punlee K, Kangkagate C, Chaithiraphan S. Reliability of Thai version of SF-36 questionnaire for the evaluation of quality of life in cardiac patients. J Med Assoc Thai. 2000 Nov;83 Suppl 2:S130-6.
Individual participant dataSharing planned: No

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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.

Wannaporn Tongtako principal investigator

Chulalongkorn University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 3 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 18 Oct 2023. 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 Thailand. 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?

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?

Apnea-Hypopnea index (event/hr) (time frame: Change from Baseline Apnea-Hypopnea index at 12 weeks.). The study lists 6 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 NCT06087900, which also lists 5 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 18 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.