New Perspective on Exploring the Post-apneic BP Surge in Patients With OSA

NCT06172998 | Unknown Early Phase 1

• 1 other identifier: Huaian1PH8
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The nocturnal short-term BPV induced by sleep-breathing events is affected by many factors. The purpose of the study is as follows: (1) to explore the relationship between nocturnal short-term BPV and vascular endothelial function and sympathetic activity in patients with OSA respectively, (2) to explore which play the key role in BP fluctuation, (3) how to prevent the frequent BP fluctuation and arrive at a safe point.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Number of Participants with high nocturnal short-term BPV will change

  one night

Study Arms (3)

healthy subject

NO INTERVENTION

low BPV group

NO INTERVENTION

high BPV group

EXPERIMENTAL

Drug: Phentolamine Injection

Interventions

Phentolamine Injection DRUG

Under patient safety, Phentolamine will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent sympathetic overactivity. Under patient safety, Nitroglycerin will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent endothelial dysfunction.

Also known as: Nitroglycerin

high BPV group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xu J: lead

Study Sites (1)

Jing Xu

Huai'an, Jiangsu, 223300, China

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Phentolamine; Nitroglycerin

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitro Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 15, 2023
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)