Obstructive Sleep ApneaNCT06393023
The Effect of OSA on Severity and Prognosis of Patients With CKD
An observational study of Obstructive Sleep Apnea and Chronic Kidney Diseases, run by Peking University First Hospital.
Trial summary
This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with chronic kidney disease (CKD), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Chronic Kidney Diseases
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 30 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with both OSA and chronic kidney disease
Who may be able to join
- Diagnostic criteria: Chronic kidney disease is diagnosed based on clinical manifestations (such as hematuria, proteinuria, abnormal renal function, etc.), in accordance with the internationally recognized diagnostic criteria. Obstructive sleep apnea-hypopnea syndrome (OSAHS) is confirmed through overnight polysomnography (PSG) with an apnea-hypopnea index (AHI) of ≥5 events per hour, primarily consisting of obstructive events.
- Age and gender: Participants must be ≥18 years old, with no gender restrictions.
- Informed consent: Participants are required to voluntarily sign a written informed consent form, acknowledging and agreeing to participate in the study, including all its contents and potential risks.
Who cannot join
- Other sleep-related breathing disorders: Participants with mixed sleep apnea, central sleep apnea, or severe snoring with an AHI index of <5 events per hour will be excluded to ensure that the study population is limited to patients with OSAHS.
- Severe internal medical conditions: Patients with severe cardiopulmonary dysfunction, malignancy, severe liver disease, mental disorders, or other severe internal medical conditions that may significantly affect sleep or the progression of kidney disease will be excluded.
- Recent surgery or medication: Individuals who have undergone surgery within the past 3 months that may affect sleep or kidney function, or who are currently using medications that may significantly interfere with sleep or the assessment of kidney disease (such as corticosteroids, immunosuppressants, novel antipsychotics, etc.) will be excluded.
- Pregnant women.
- Inability to cooperate with the study: Patients who are unable to complete the study procedures (including polysomnography, follow-up, etc.) due to cognitive impairment, language communication difficulties, remote residence, or other reasons will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Obstructive Sleep Apnea on Severity and Prognosis of Patients With Chronic Kidney Disease
This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with chronic kidney disease (CKD), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Although the study is designed as an observational cohort study, where patients self-selected whether to receive treatment rather than being assigned, there is still an intervention project, CPAP, present in the observational cohort. Through a cohort study design, scientific evidences are expected for clinical decision-making and optimize treatment strategies for patients with OSA and CKD.
- Conditions
- Obstructive Sleep Apnea, Chronic Kidney Diseases
- Being tested
- Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Although this study is designed as an observational cohort study, where patients were not assigned to intervention or non-intervention groups, there is still an intervention project indicator present in the observational cohort. The intervention in this study involves the use of Continuous Positive Airway Pressure (CPAP) treatment. CPAP is a commonly used therapy for obstructive sleep apnea (OSA) and other sleep-related breathing disorders. The principle of CPAP treatment lies in maintaining a constant airway pressure during sleep to prevent the collapse of the upper airway and ensure unobstructed breathing. The patient wears a mask connected to a CPAP machine, which generates a steady stream of air to provide the necessary pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Measured: 2 years
Secondary outcomes (2)
Rate of kidney failure
Measured: 5 years
Kidney dialysis rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowan Du, Peking University First Hospital
- Investigators
- Xiaowan Du, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393023
- Sponsor's protocol ID
- PekingUFH ENT OSACKD V1.0
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obstructive Sleep Apnea on Severity and Prognosis of Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06393023
- Acronym / sponsor ID
- PekingUFH ENT OSACKD V1.0
- Conditions
- Obstructive Sleep Apnea, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 May 2024 (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.
This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with chronic kidney disease (CKD), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Although the study is designed as an observational cohort study, where patients self-selected whether to receive treatment rather than being assigned, there is still an intervention project, CPAP, present in the observational cohort. Through a cohort study design, scientific evidences are expected for clinical decision-making and optimize treatment strategies for patients with OSA and CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with both OSA and chronic kidney disease
Key inclusion criteria (3 listed)
- Diagnostic criteria: Chronic kidney disease is diagnosed based on clinical manifestations (such as hematuria, proteinuria, abnormal renal function, etc.), in accordance with the internationally recognized diagnostic criteria. Obstructive sleep apnea-hypopnea syndrome (OSAHS) is confirmed through overnight polysomnography (PSG) with an apnea-hypopnea index (AHI) of ≥5 events per hour, primarily consisting of obstructive events.
- Age and gender: Participants must be ≥18 years old, with no gender restrictions.
- Informed consent: Participants are required to voluntarily sign a written informed consent form, acknowledging and agreeing to participate in the study, including all its contents and potential risks.
Key exclusion criteria (5 listed)
- Other sleep-related breathing disorders: Participants with mixed sleep apnea, central sleep apnea, or severe snoring with an AHI index of <5 events per hour will be excluded to ensure that the study population is limited to patients with OSAHS.
- Severe internal medical conditions: Patients with severe cardiopulmonary dysfunction, malignancy, severe liver disease, mental disorders, or other severe internal medical conditions that may significantly affect sleep or the progression of kidney disease will be excluded.
- Recent surgery or medication: Individuals who have undergone surgery within the past 3 months that may affect sleep or kidney function, or who are currently using medications that may significantly interfere with sleep or the assessment of kidney disease (such as corticosteroids, immunosuppressants, novel antipsychotics, etc.) will be excluded.
- Pregnant women.
- Inability to cooperate with the study: Patients who are unable to complete the study procedures (including polysomnography, follow-up, etc.) due to cognitive impairment, language communication difficulties, remote residence, or other reasons will be excluded.
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 PressureAlthough this study is designed as an observational cohort study, where patients were not assigned to intervention or non-intervention groups, there is still an intervention project indicator present in the observational cohort. The intervention in this study involves the use of Continuous Positive Airway Pressure (CPAP) treatment. CPAP is a commonly used therapy for obstructive sleep apnea (OSA) and other sleep-related breathing disorders. The principle of CPAP treatment lies in maintaining a constant airway pressure during sleep to prevent the collapse of the upper airway and ensure unobstructed breathing. The patient wears a mask connected to a CPAP machine, which generates a steady stream of air to provide the necessary pressure. | Device | – |
Primary outcome
Acute kidney injury
Time frame: 2 years
2 secondary outcomes
Rate of kidney failure
Time frame: 5 years
Kidney dialysis rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No. Individual participant data will be provided upon request.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Xiaowan Du study director
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Chronic Kidney Diseases, run by Peking University First Hospital.
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 3 inclusion and 5 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 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaowan Du (13552834319, xiaowandu26@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.