Exploring Blood Pressure Variability in Obstructive Sleep Apnea Patients
New Perspective on Exploring the Post-apneic Blood Pressure Surge in Patients With Obstructive Sleep Apnea
EARLY_PHASE1 · Huai'an No.1 People's Hospital · NCT06172998
This study is trying to see how changes in blood pressure during sleep affect people with obstructive sleep apnea and whether a certain medication can help manage those changes.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Huai'an No.1 People's Hospital (other) |
| Locations | 1 site (Huai'an, Jiangsu) |
| Trial ID | NCT06172998 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between nocturnal short-term blood pressure variability (BPV) and vascular endothelial function as well as sympathetic activity in patients with obstructive sleep apnea (OSA). It aims to identify the key factors influencing BP fluctuations during sleep and to develop strategies to prevent these fluctuations. Approximately 300 suspected OSA patients and 50 healthy subjects will undergo full-night polysomnography to gather data on their blood pressure responses during sleep events. The intervention involves administering phentolamine injections to assess its effects on BPV.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with medium to severe obstructive sleep apnea.
Not a fit: Patients with other sleep disorders or significant comorbidities such as hypertension or cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood pressure fluctuations in patients with obstructive sleep apnea, potentially reducing cardiovascular risks.
How similar studies have performed: While studies on blood pressure variability in OSA exist, this specific approach focusing on the mechanisms of BP fluctuation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * medium to severe OSA (apnea-hypopnea index, AHI≥15 events/h) and patients without OSA (AHI\<5 events/h) * age from 18 to 65 years old. Exclusion Criteria: * combined with other sleep disorders * patients with comorbidities, such as hypertension, diabetes, cardiovascular diseases, and cerebrovascular diseases etc * conditions that potentially affect the accuracy of BPV and endothelial function * ever-received the treatment of constructive positive airway pressure (CPAP) * who refuse to participate in the study.
Where this trial is running
Huai'an, Jiangsu
- Jing Xu — Huai'an, Jiangsu, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea