Nocturnal Hypertension Complicated with Obstructive Sleep Apnea
Conditions
Interventions
intra-oral negative air pressure therapy :intra-oral negative air pressure therapy for 4 weeks
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, male or female. 2. Body mass index (BMI) = 120 mmHg and/or diastolic blood pressure >= 70 mmHg), confirmed by 24-hour ambulatory blood pressure monitoring (ABPM). 5. Stable use of antihypertensive drugs with no adjustment to the types and doses in the 4 weeks prior to enrollment; and no planned adjustment to the types and doses of antihypertensive drugs within at least 30 days after enrollment. 6. Passed the adaptability test of the iNAP device (no obvious oral discomfort, nausea or other adverse reactions after 30 minutes of wearing). 7. Voluntarily signed the informed consent form and was able to cooperate with the completion of follow-up visits.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to the silicone accessories of the iNAP device. 2. Severe nasal obstructive diseases (e.g., nasal polyps, moderate to severe chronic rhinitis) that impair nasal respiratory function. 3. Severe periodontal disease or oral surgery within the recent 3 months, with inability to maintain oral tight seal. 4. Acute cardiovascular and cerebrovascular events (e.g., myocardial infarction, cerebral infarction) or acute exacerbation of moderate to severe pulmonary diseases (e.g., acute COPD exacerbation) within the recent 6 months. 5. Comorbid with other sleep disorders (e.g., primary insomnia, narcolepsy, restless legs syndrome) that may interfere with the assessment of OSA. 6. Confirmed central sleep apnea (central apnea index >=5 events/hour, or central apnea accounting for 50% or more of the total AHI). 7. Patients with hypoxemia (SpO2<80%) caused by cardiac diseases (e.g., myocardial infarction, heart failure) or severe pulmonary/respiratory system diseases (e.g., acute exacerbation of chronic obstructive pulmonary disease, interstitial lung disease, pneumothorax, pneumonia) within the recent 6 months, excluding hypoxemia induced by OSA. 8. Diagnosis of malignant tumors, mental disorders (e.g., schizophrenia, severe depression), or other conditions with inability to cooperate with the study procedures. 9. Concurrent participation in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean reduction in nocturnal systolic blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average nocturnal systolic blood pressure;Average nocturnal diastolic blood pressure;24-hour average blood pressure;Average blood pressure during the day;The increase in blood pressure in the early morning;blood pressure variability;Nocturnal blood pressure decline rate;AHI decline rate;lowest oxygen saturation;Stanislav Epworth Sleepiness Scale;Sleep Quality Questionnaire;Clinical Global Impression Scale;Clinical Memory Test;Montreal Cognitive Assessment; | — |
Countries
China
Contacts
Public ContactWang Yunhong
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed