Obstructive Sleep Apnea of AdultNCT03839654
Loop Gain in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement
A study testing continuous positive airway pressure in people with Obstructive Sleep Apnea of Adult and Heart Valve Diseases, run by Nanjing Medical University at 1 site in China.
Trial summary
Sleep apnea including obstructive sleep apnea (OSA) and central sleep apnea (CSA), are common in patients with cardiovascular disease. The prevalence of OSA is 2%-4% in general population and 16%-47% in surgical-heart failure patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Heart Valve Diseases
- What is being tested?
- continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2020to 31 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years.
- Patients with heart valve disease.
- Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h).
- Received cardiac valve replacement surgery.
- The enrolled patients having received patients' informed consent.
Who cannot join
- History of stroke or clinical signs of peripheral or central nervous system disorders.
- History of chronic obstructive pulmonary disease or asthma.
- Enrolment in another clinical study.
Trial locations and contacts
1 site in 1 country.
Ning Ding, Ph D contact
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Hong Wang, Ph D, 25 68306723, drhongwang@163.com
Ding Ning, Ph D, dr.ningding@live.cn
About this study
Official title: The Role and Mechanisms of Loop Gain and Associated Parameters in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement
Sleep apnea including obstructive sleep apnea (OSA) and central sleep apnea (CSA), are common in patients with cardiovascular disease. The prevalence of OSA is 2%-4% in general population and 16%-47% in surgical-heart failure patients.
The previous studies found that the sleep apnea types shifted from OSA to CSA after continuous positive airway pressure (CPAP) treatment or from CSA to OSA after heart surgery (cardiac valve replacement/ repair or heart transplantation) without the mechanism illuminated clearly. The recent studies found that the loop gain (LG) could predict the effect of upper airway surgery and CPAP treatment on the reversion of OSA. However, in patients with valvular heart disease, whether LG and related parameters can predict the therapeutic efficacy of CPAP or cardiac valve replacement is not expounded clearly.
Read more
The investigators' previous study found that there were different outcomes of sleep apnea after cardiac valve replacement: elimination or consistent. But the corresponding non-anatomic mechanisms was not clear. The investigators' preliminary experiment showed that the LG and related parameters were not improved while OSA improved by CPAP treatment; however, the recovery of OSA after cardiac valve replacement was closed related to the improvement of LG and related parameters.
The investigators speculated that, 1. LG and related parameters could predict OSA outcome of CPAP treatment or cardiac valve replacement. 2. non-anatomic mechanisms including LG and associated parameters, contributed to CPAP treatment and cardiac valve replacement were different. In this study, the investigators aimed to explore the relationship between LG and, outcomes of OSA and the regarding non-anatomic mechanisms in patient with heart valve disease.
Read the detailed description
Between January 31, 2020 and June 30, 2023, 300 patients with valvular heart disease waiting for cardiac valve replacement in Department of Cardiovascular Surgery were screened for obstructive sleep apnea (OSA) by full-night polysomnography. Of them, 40 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (20:20).
The CPAP treatment group received both baseline medicine and CPAP treatment. The full-night CPAP treatment was conducted from 21:00 pm to 6:00 am for 7 days preoperatively. The non-CPAP treatment group received baseline medicine treatment. LG and related parameters were collected at the first day of treatment in non-CPAP group and both first and last day of treatment in CPAP group.
Sleep parameters including apnea-hypopnea index (AHI), mean and lowest SPO2, and clinical evaluations including New York Heart Association (NYHA) classes, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test were recorded.
Operation related parameters (duration of operation, duration of cardiopulmonary bypass and bleeding volume) were recorded. Postoperative adverse events such as duration of ICU stay, postoperative duration of mechanical ventilation, pacemaker use, complicated infection and reintubations were recorded.
A full-night polysomnography as well as LG and related parameters were re-examined before discharge from hospital. The changes of AHIs, mean and lowest SPO2, LG and related parameters between pre- and post-operative polysomnography parameters were calculated.
The correlation between changes of polysomnography and LG parameters pre- and post-CPAP in CPAP group were analyzed. The correlation between changes of polysomnography and LG parameters pre- and post-operative in both CPAP and non-CPAP group were analyzed. The differences of polysomnography and LG parameters, and post-operative adverse events between CPAP and non-CPAP treatment group were analyzed.
- Being tested
- continuous positive airway pressure
- Keywords
- Obstructive Sleep Apnea, heart valve replacement, CPAP treatment, loop gain
- Medical subject headings
- Heart Valve Diseases, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure | Experimental | The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively. Receives: Device: continuous positive airway pressure |
| non-continuous positive airway pressure | No intervention | The non-CPAP treatment group received baseline medicine treatment without CPAP treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of apnea-hypopnea index
Changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
Measured: 14 days
changes of lowest SPO2
Changes of lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients.
Measured: 14 days
comparison of loop gain
Loop gain pre- and post-operative was compared between CPAP and non-CPAP patients.
Loop gain pre- and post-CPAP treatment were compared in CPAP group.
Measured: 7 days
arousal threshold
Arousal threshold pre- and post-operative was compared between CPAP and non-CPAP patients.
Arousal threshold pre- and post-CPAP treatment were compared in CPAP group.
Measured: 14 days
upper airway gain
Upper airway gain pre- and post-operative was compared between CPAP and non-CPAP patients.
Upper airway gain pre- and post-CPAP treatment were compared in CPAP group.
Measured: 14 days
Secondary outcomes (4)
duration of operation
Duration of operation was compared between CPAP and non-CPAP patients.
Measured: 12 hours
duration of cardiopulmonary bypass
Duration of cardiopulmonary bypass was compared between CPAP and non-CPAP patients.
Measured: 12 hours
duration of ICU stays
Duration of ICU stays were compared between CPAP and non-CPAP patients.
Measured: 14 days
duration of mechanical ventilation
Postoperative duration of mechanical ventilation was compared between CPAP and non-CPAP patients.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start31 Jan 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 300 patients with rheumatic valvular heart disease waiting for cardiac valve replacement were screened for obstructive sleep apnea (OSA). Of them, 40 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (20:20 patients). The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline medicine treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Ding, Nanjing Medical University
- Investigators
- Hong Wang, Ph D, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839654
- Sponsor's protocol ID
- 2019-SR-016
- Status last verified
- Mar 2021
- First submitted
- 7 Feb 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding N, Ni BQ, Zhang XL, Zha WJ, Hutchinson SZ, Lin W, Huang M, Zhang SJ, Wang H. Elimination of central sleep apnea by cardiac valve replacement: a continuous follow-up study in patients with rheumatic valvular heart disease. Sleep Med. 2014 Aug;15(8):880-6. doi: 10.1016/j.sleep.2014.02.007. Epub 2014 May 17.
PubMed 24938583Ding N, Ni BQ, Wang H, Ding WX, Xue R, Lin W, Kai Z, Zhang SJ, Zhang XL. Obstructive Sleep Apnea Increases the Perioperative Risk of Cardiac Valve Replacement Surgery: A Prospective Single-Center Study. J Clin Sleep Med. 2016 Oct 15;12(10):1331-1337. doi: 10.5664/jcsm.6182.
PubMed 27448416
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Mechanisms of Loop Gain and Associated Parameters in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement
- ClinicalTrials.gov ID
- NCT03839654
- Acronym / sponsor ID
- 2019-SR-016
- Keywords
- Obstructive Sleep Apnea, heart valve replacement, CPAP treatment, loop gain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Feb 2019 (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.
Sleep apnea including obstructive sleep apnea (OSA) and central sleep apnea (CSA), are common in patients with cardiovascular disease. The prevalence of OSA is 2%-4% in general population and 16%-47% in surgical-heart failure patients.
The previous studies found that the sleep apnea types shifted from OSA to CSA after continuous positive airway pressure (CPAP) treatment or from CSA to OSA after heart surgery (cardiac valve replacement/ repair or heart transplantation) without the mechanism illuminated clearly. The recent studies found that the loop gain (LG) could predict the effect of upper airway surgery and CPAP treatment on the reversion of OSA. However, in patients with valvular heart disease, whether LG and related parameters can predict the therapeutic efficacy of CPAP or cardiac valve replacement is not expounded clearly.
The investigators' previous study found that there were different outcomes of sleep apnea after cardiac valve replacement: elimination or consistent. But the corresponding non-anatomic mechanisms was not clear. The investigators' preliminary experiment showed that the LG and related parameters were not improved while OSA improved by CPAP treatment; however, the recovery of OSA after cardiac valve replacement was closed related to the improvement of LG and related parameters.
The investigators speculated that, 1. LG and related parameters could predict OSA outcome of CPAP treatment or cardiac valve replacement. 2. non-anatomic mechanisms including LG and associated parameters, contributed to CPAP treatment and cardiac valve replacement were different. In this study, the investigators aimed to explore the relationship between LG and, outcomes of OSA and the regarding non-anatomic mechanisms in patient with heart valve disease.
Detailed description
Between January 31, 2020 and June 30, 2023, 300 patients with valvular heart disease waiting for cardiac valve replacement in Department of Cardiovascular Surgery were screened for obstructive sleep apnea (OSA) by full-night polysomnography. Of them, 40 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (20:20).
The CPAP treatment group received both baseline medicine and CPAP treatment. The full-night CPAP treatment was conducted from 21:00 pm to 6:00 am for 7 days preoperatively. The non-CPAP treatment group received baseline medicine treatment. LG and related parameters were collected at the first day of treatment in non-CPAP group and both first and last day of treatment in CPAP group.
Sleep parameters including apnea-hypopnea index (AHI), mean and lowest SPO2, and clinical evaluations including New York Heart Association (NYHA) classes, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test were recorded.
Operation related parameters (duration of operation, duration of cardiopulmonary bypass and bleeding volume) were recorded. Postoperative adverse events such as duration of ICU stay, postoperative duration of mechanical ventilation, pacemaker use, complicated infection and reintubations were recorded.
A full-night polysomnography as well as LG and related parameters were re-examined before discharge from hospital. The changes of AHIs, mean and lowest SPO2, LG and related parameters between pre- and post-operative polysomnography parameters were calculated.
The correlation between changes of polysomnography and LG parameters pre- and post-CPAP in CPAP group were analyzed. The correlation between changes of polysomnography and LG parameters pre- and post-operative in both CPAP and non-CPAP group were analyzed. The differences of polysomnography and LG parameters, and post-operative adverse events between CPAP and non-CPAP treatment group were analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 300 patients with rheumatic valvular heart disease waiting for cardiac valve replacement were screened for obstructive sleep apnea (OSA). Of them, 40 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (20:20 patients). The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline medicine treatment.
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure | Experimental | Device: continuous positive airway pressureThe CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively. |
| non-continuous positive airway pressure | No intervention | –The non-CPAP treatment group received baseline medicine treatment without CPAP treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-75 years.
- Patients with heart valve disease.
- Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h).
- Received cardiac valve replacement surgery.
- The enrolled patients having received patients' informed consent.
Key exclusion criteria (3 listed)
- History of stroke or clinical signs of peripheral or central nervous system disorders.
- History of chronic obstructive pulmonary disease or asthma.
- Enrolment in another clinical study.
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 |
|---|---|---|
| continuous positive airway pressureThe CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively. | Device | continuous positive airway pressure |
Primary outcome
changes of apnea-hypopnea index
Time frame: 14 days
Changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
changes of lowest SPO2
Time frame: 14 days
Changes of lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients.
comparison of loop gain
Time frame: 7 days
Loop gain pre- and post-operative was compared between CPAP and non-CPAP patients. Loop gain pre- and post-CPAP treatment were compared in CPAP group.
arousal threshold
Time frame: 14 days
Arousal threshold pre- and post-operative was compared between CPAP and non-CPAP patients. Arousal threshold pre- and post-CPAP treatment were compared in CPAP group.
upper airway gain
Time frame: 14 days
Upper airway gain pre- and post-operative was compared between CPAP and non-CPAP patients. Upper airway gain pre- and post-CPAP treatment were compared in CPAP group.
4 secondary outcomes
duration of operation
Time frame: 12 hours
duration of cardiopulmonary bypass
Time frame: 12 hours
duration of ICU stays
Time frame: 14 days
duration of mechanical ventilation
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 24938583Ding N, Ni BQ, Zhang XL, Zha WJ, Hutchinson SZ, Lin W, Huang M, Zhang SJ, Wang H. Elimination of central sleep apnea by cardiac valve replacement: a continuous follow-up study in patients with rheumatic valvular heart disease. Sleep Med. 2014 Aug;15(8):880-6. doi: 10.1016/j.sleep.2014.02.007. Epub 2014 May 17.
- Background: PubMed 27448416Ding N, Ni BQ, Wang H, Ding WX, Xue R, Lin W, Kai Z, Zhang SJ, Zhang XL. Obstructive Sleep Apnea Increases the Perioperative Risk of Cardiac Valve Replacement Surgery: A Prospective Single-Center Study. J Clin Sleep Med. 2016 Oct 15;12(10):1331-1337. doi: 10.5664/jcsm.6182.
Related trials for Obstructive Sleep Apnea of Adult
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
RecruitingPhase 4
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
Obstructive Sleep Apnea (OSA)
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.
Ning Ding, Ph D contact
Hong Wang, Ph D study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure in people with Obstructive Sleep Apnea of Adult and Heart Valve Diseases, run by Nanjing Medical University at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Mar 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 China. 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 Hong Wang, Ph D (8602568306723, drhongwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of apnea-hypopnea index (time frame: 14 days). The study lists 5 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 NCT03839654, which also lists 2 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 10 Mar 2021.