Obstructive Sleep ApneaNCT05014529
The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity.
An observational study of Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The ROCK (Rho-associated coiled-coil containing kinases) play a critical role in the pathogenesis of cardiovascular diseases and left ventricle hypertrophy (LVH). ROCK activity can be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- Type of treatment
- Pill or oral medicine
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to Dec 2024
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who have snoring or any other symptoms of sleep breathing disorders receive a standard polysomnography study in the Chang Gung Sleep Center of Keelung.
Who may be able to join
- ● Subjects who complete a standard polysomnography study.
Who cannot join
- Patients who have heart failure (as determined by clinical symptoms or signs with elevated brain natriuretic peptide and echocardiography showing structural or functional abnormalities)
- Coronary artery disease (stress electrocardiography, myocardial scintigraphy, or coronary angiography proven coronary artery lesion)
- Hypertrophic cardiomyopathy
- Known infiltrative disease e.g. amyloidosis
- Chronic kidney disease severe than stage III
- Ischemic or hemorrhagic stroke
Show all 13Show fewer
- Central sleep apnea,
- Hypoventilation syndrome (TCO2 or artery PaCO2 exceed 50 mmHg)
- Unstable hemodynamic state
- Eastern Cooperative Oncology Group Performance Status higher than grade 2
- Pregnant women will be excluded.
- Polysomnography exam showing sleep time less than 2 hours
- Patients who receive surgery or oral appliance during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity and Left Ventricle Mass in Obstructive Sleep Apnea-hypopnea Syndrome.
The ROCK (Rho-associated coiled-coil containing kinases) play a critical role in the pathogenesis of cardiovascular diseases and left ventricle hypertrophy (LVH). ROCK activity can be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. Obstructive sleep apnea (OSA) increase cardiovascular disease and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA. This study investigate the effect of CPAP on ROCK activity and left ventricle mass.
Read the detailed description
The ROCK were discovered as downstream targets of Ras homologous A and regulate various important cellular functions, including proliferation, migration, adhesion, and apoptosis. They play a critical role in the pathogenesis of cardiovascular diseases, including cardiac fibrosis, hypertrophy, and remodeling. ROCK activity can be detected in human circulating leukocytes and could potentially be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. It has been proven that higher ROCK activity is present in left ventricle hypertrophy (LVH) patients than those without LVH. Obstructive sleep apnea(OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep that leads to intermittent nocturnal hypoxia, resulting in a broad range of cardiovascular morbidities, including coronary artery disease, heart failure, cardiac arrhythmias, and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA and several studies have shown that it can effectively reduce cardiovascular disease, but the effect of CPAP on left ventricle mass reduction is still uncertain. Previous studies demonstrated that patients with OSA had higher circulatory ROCK activity than those without OSA, but the role of CPAP on ROCK activity is not known. The circulatory leukocyte ROCK activity may be used as a clinical biomarker for cardiovascular disease and ROCK inhibitors may be used in the future as a treatment. OSA and CPAP treatment may also affect ROCK activity, the relationship between CPAP treatment, cardiac hypertrophy, and ROCK activity is important and should be clarified. Therefore, the main purpose of our study is to evaluate the effect of CPAP on ROCK activity and left ventricle mass.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Continuous positive airway pressure, Rho-associated coiled-coil containing kinases, Left ventricle mass
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Polysomography show AHI less than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months. | |
| OSA without CPAP group | Polysomography show AHI greater than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months. | |
| OSA with CPAP group | Polysomography show AHI greater than 15 events/h and participants receive CPAP more than 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROCK activity
Compare the change of blood ROCK 1, ROCK 2, and MYTP-1 p/t (The levels of phosphorylated to total myosin light chain phosphatase 1) among those three groups.
Measured: Check baseline blood ROCK 1, ROCK 2, and MYTP-1 p/t and follow up these levels in six months later.
Left ventricle mass
Compare the change left ventricle mass index among those three groups.
Measured: Do baseline echocardiography and follow up echocardiography in six months later.
Secondary outcomes (1)
Blood pressure
Compare the blood pressure among those three groups.
Measured: Obtain initial and blood pressure six months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Oct 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung-Chieh, Yu, Chang Gung Memorial Hospital
- Investigators
- Sleep center, Principal investigator, Chang Gung Memorial Hospital, Keelung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014529
- Sponsor's protocol ID
- 202009223870
- Status last verified
- Sep 2021
- First submitted
- 14 Aug 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requestors need application and explain the purpose. The data access will be provided after approved by review panel.
Publications
Julian L, Olson MF. Rho-associated coiled-coil containing kinases (ROCK): structure, regulation, and functions. Small GTPases. 2014;5:e29846. doi: 10.4161/sgtp.29846. Epub 2014 Jul 10.
PubMed 25010901Sekizuka H, Osada N, Akashi YJ. Impact of obstructive sleep apnea and hypertension on left ventricular hypertrophy in Japanese patients. Hypertens Res. 2017 May;40(5):477-482. doi: 10.1038/hr.2016.170. Epub 2016 Dec 1.
PubMed 27904155Stewart MH, Lavie CJ, Shah S, Englert J, Gilliland Y, Qamruddin S, Dinshaw H, Cash M, Ventura H, Milani R. Prognostic Implications of Left Ventricular Hypertrophy. Prog Cardiovasc Dis. 2018 Nov-Dec;61(5-6):446-455. doi: 10.1016/j.pcad.2018.11.002. Epub 2018 Nov 6.
PubMed 30408469Zhang L, Zhuang JH, Peng H, Huang J, Huang LQ, Zhao ZX. Correlation between endothelial dysfunction, Rho-associated protein kinase activity, C-reactive protein and obstructive sleep apnoea syndrome in male patients. J Int Med Res. 2012;40(6):2183-90. doi: 10.1177/030006051204000616.
PubMed 23321175
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity and Left Ventricle Mass in Obstructive Sleep Apnea-hypopnea Syndrome.
- ClinicalTrials.gov ID
- NCT05014529
- Acronym / sponsor ID
- 202009223870
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Continuous positive airway pressure, Rho-associated coiled-coil containing kinases, Left ventricle mass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Aug 2021 (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 ROCK (Rho-associated coiled-coil containing kinases) play a critical role in the pathogenesis of cardiovascular diseases and left ventricle hypertrophy (LVH). ROCK activity can be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. Obstructive sleep apnea (OSA) increase cardiovascular disease and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA. This study investigate the effect of CPAP on ROCK activity and left ventricle mass.
Detailed description
The ROCK were discovered as downstream targets of Ras homologous A and regulate various important cellular functions, including proliferation, migration, adhesion, and apoptosis. They play a critical role in the pathogenesis of cardiovascular diseases, including cardiac fibrosis, hypertrophy, and remodeling. ROCK activity can be detected in human circulating leukocytes and could potentially be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. It has been proven that higher ROCK activity is present in left ventricle hypertrophy (LVH) patients than those without LVH. Obstructive sleep apnea(OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep that leads to intermittent nocturnal hypoxia, resulting in a broad range of cardiovascular morbidities, including coronary artery disease, heart failure, cardiac arrhythmias, and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA and several studies have shown that it can effectively reduce cardiovascular disease, but the effect of CPAP on left ventricle mass reduction is still uncertain. Previous studies demonstrated that patients with OSA had higher circulatory ROCK activity than those without OSA, but the role of CPAP on ROCK activity is not known. The circulatory leukocyte ROCK activity may be used as a clinical biomarker for cardiovascular disease and ROCK inhibitors may be used in the future as a treatment. OSA and CPAP treatment may also affect ROCK activity, the relationship between CPAP treatment, cardiac hypertrophy, and ROCK activity is important and should be clarified. Therefore, the main purpose of our study is to evaluate the effect of CPAP on ROCK activity and left ventricle mass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Polysomography show AHI less than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months. |
| OSA without CPAP group | – | –Polysomography show AHI greater than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months. |
| OSA with CPAP group | – | –Polysomography show AHI greater than 15 events/h and participants receive CPAP more than 6 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have snoring or any other symptoms of sleep breathing disorders receive a standard polysomnography study in the Chang Gung Sleep Center of Keelung.
Key inclusion criteria (1 listed)
- ● Subjects who complete a standard polysomnography study.
Key exclusion criteria (13 listed)
- Patients who have heart failure (as determined by clinical symptoms or signs with elevated brain natriuretic peptide and echocardiography showing structural or functional abnormalities)
- Coronary artery disease (stress electrocardiography, myocardial scintigraphy, or coronary angiography proven coronary artery lesion)
- Hypertrophic cardiomyopathy
- Known infiltrative disease e.g. amyloidosis
- Chronic kidney disease severe than stage III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ROCK activity
Time frame: Check baseline blood ROCK 1, ROCK 2, and MYTP-1 p/t and follow up these levels in six months later.
Compare the change of blood ROCK 1, ROCK 2, and MYTP-1 p/t (The levels of phosphorylated to total myosin light chain phosphatase 1) among those three groups.
Left ventricle mass
Time frame: Do baseline echocardiography and follow up echocardiography in six months later.
Compare the change left ventricle mass index among those three groups.
1 secondary outcome
Blood pressure
Time frame: Obtain initial and blood pressure six months later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 25010901Julian L, Olson MF. Rho-associated coiled-coil containing kinases (ROCK): structure, regulation, and functions. Small GTPases. 2014;5:e29846. doi: 10.4161/sgtp.29846. Epub 2014 Jul 10.
- Background: PubMed 27904155Sekizuka H, Osada N, Akashi YJ. Impact of obstructive sleep apnea and hypertension on left ventricular hypertrophy in Japanese patients. Hypertens Res. 2017 May;40(5):477-482. doi: 10.1038/hr.2016.170. Epub 2016 Dec 1.
- Background: PubMed 30408469Stewart MH, Lavie CJ, Shah S, Englert J, Gilliland Y, Qamruddin S, Dinshaw H, Cash M, Ventura H, Milani R. Prognostic Implications of Left Ventricular Hypertrophy. Prog Cardiovasc Dis. 2018 Nov-Dec;61(5-6):446-455. doi: 10.1016/j.pcad.2018.11.002. Epub 2018 Nov 6.
- Background: PubMed 23321175Zhang L, Zhuang JH, Peng H, Huang J, Huang LQ, Zhao ZX. Correlation between endothelial dysfunction, Rho-associated protein kinase activity, C-reactive protein and obstructive sleep apnoea syndrome in male patients. J Int Med Res. 2012;40(6):2183-90. doi: 10.1177/030006051204000616.
- Individual participant dataSharing planned: Undecided. Requestors need application and explain the purpose. The data access will be provided after approved by review panel.
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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.
Sleep center principal investigator
Chang Gung Memorial Hospital, Keelung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Sep 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung-Chieh Yu, MD (886+22432-9292 ext. 2657, terminatorchieh@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROCK activity (time frame: Check baseline blood ROCK 1, ROCK 2, and MYTP-1 p/t and follow up these levels in six months later.). 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 NCT05014529, which also lists 4 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 24 Sep 2021.