NCT06608888 Unveiling the Neural Mechanisms of 5-HT7 in Sleep Apnea Induced by Arousal Dysregulation
| NCT ID | NCT06608888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tsinghua Chang Gung Hospital |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-08-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2024-08-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Obstructive sleep apnea (OSA), recognized as a highly prevalent sleep breathing disorder with severe complications, features a complex etiology. Poor understanding of disease pathogenesis limits the overall efficacy of interventions. Studies have found that upregulation of 5-HT7 expression in the lateral hypothalamus (LH) could reduce arousal threshold (ArTH) and induce an inhibitory effect to the respiratory central, which was associated with hypoxic stimulation. Therefore, the investigators speculate that the structural/functional abnormalities of the arousal-respiratory neural circuit, mediated by LH5-HT7, may play an important role in the pathogenesis of OSA. To verify the hypothesis, the investigators will compare the ArTH and the brain network presenting by multimodal MRI in normal individuals, snoring individuals, and OSA patients, to reveal the correlation between arousal dysregulation and the structure/function of LH regions; compare the changes of ArTH and brain network in OSA patients with low ArTH before and after CPAP treatment, to verify the interaction between hypoxia and arousal dysregulation, as well as whether the damaging performance of the arousal-respiratory brain regulation area in OSA patients can be partially reversed by relieving hypoxia. Above all, the joint application B team will further analyze the LH5-HT7 neural mechanism in the pathogenesis of OSA.
Eligibility Criteria
Inclusion Criteria: OSA Patients: * Age between 20 and 60 years. * Symptoms of sleep snoring and daytime sleepiness. * Confirmed diagnosis of OSA following overnight sleep monitoring. Simple Snorers: * Age between 20 and 60 years. * Symptoms of sleep snoring. * Overnight sleep monitoring indicates not meeting the OSA diagnosis. Healthy Controls: * Age between 20 and 60 years. * No symptoms of sleep snoring. * Overnight sleep monitoring rules out the diagnosis of OSA. Exclusion Criteria: * Presence of severe pulmonary, neurological, or cardiovascular complications. * History of long-term non-invasive positive pressure ventilation treatment (more than 3 months) or upper airway surgery. * Sleep-disordered breathing due to special etiologies such as hypothyroidism, acromegaly, vocal cord paralysis, etc. * Presence of severe mental illness, long-term alcohol abuse, or a history of prolonged use of sedative-hypnotic drugs. * Central sleep apnea predominant sleep disorders due to various causes. * Severe craniofacial deformities, myasthenia gravis, or other known myopathic histories. * Patients with peripheral neuropathy caused by diabetes, autoimmune diseases, etc. * Patients with comorbid insomnia, anxiety, depression, or other types of sleep disorders.
Contact & Investigator
Jingying Ye
PRINCIPAL INVESTIGATOR
BeijingTsinghua Changgung Hospital，Tsinghua University
Frequently Asked Questions
Who can join the NCT06608888 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 60 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06608888 currently recruiting?
Yes, NCT06608888 is actively recruiting participants. Contact the research team at yingqianzhou9112@126.com for enrollment information.
Where is the NCT06608888 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06608888 clinical trial?
NCT06608888 is sponsored by Beijing Tsinghua Chang Gung Hospital. The principal investigator is Jingying Ye at BeijingTsinghua Changgung Hospital，Tsinghua University. The trial plans to enroll 140 participants.