NCT05548569

Brief Summary

It is thought that intermittent hypoxia, poor tissue oxygenation, and perfusion in OSA can lead to eNOS uncoupling. Uncoupled eNOS can reduce nitric oxide (NO), which will result in an imbalance of contraction and diastole. Furthermore, OSA may increase beat-to-to BPV via the characteristic acute blood pressure peaks that follow the end of obstructive apnoeas. Therefore, the aim is to discuss the relationship between vascular endothelial dysfunction and beat-to-beat blood pressure variability in patients with OSAS (Obstructive sleep apnea syndrome).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

September 16, 2022

Last Update Submit

March 19, 2024

Conditions

Keywords

Obstructive sleep apnea,endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Relationship Between Vascular Endothelial Dysfunction and Beat-to-beat Blood Pressure Variability in Patients With OSAS

    the endothelial dysfucntion patients with OSAS have more sever blood pressure variability

    2022.04.01-2023.04.01

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient snoring patients will have PSG, and patients aged 18 years and older will be included in the study.Inclusion Criteria:1. Moderate to severe OSA(AHI≥15 times/hour);2. Hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);Exclusion Criteria:1.Malignant tumor, severe arrhythmia and heart disease, moderate and severe renal dysfunction, peripheral vascular disease, diabetes 2.Systolic blood pressure ≤140mmHg and diastolic blood pressure ≤90mmHg 3.Vigorous exercise 24 hours before the experiment; 4.Vasoactive drugs (ACEI, ARB, CCB, β blockers, nitrates) were used 48 hours before the experiment;

You may qualify if:

  • ≥18 years old;
  • Moderate to severe OSA(AHI≥15 times/hour);
  • Hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);

You may not qualify if:

  • Malignant tumor, severe arrhythmia and heart disease, moderate and severe renal dysfunction, peripheral vascular disease, diabetes
  • Systolic blood pressure ≤140mmHg and diastolic blood pressure ≤90mmHg
  • Vigorous exercise 24 hours before the experiment;
  • Vasoactive drugs (ACEI, ARB, CCB, β blockers, nitrates) were used 48 hours before the experiment;
  • Smoking, drinking and consuming caffeinated beverages 12 hours before the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jing Xu

Huai'an, Jiangsu, 223300, China

RECRUITING

Related Publications (5)

  • Pal A, Martinez F, Aguila AP, Akey MA, Chatterjee R, Conserman MGE, Aysola RS, Henderson LA, Macey PM. Beat-to-beat blood pressure variability in patients with obstructive sleep apnea. J Clin Sleep Med. 2021 Mar 1;17(3):381-392. doi: 10.5664/jcsm.8866.

    PMID: 33089774BACKGROUND
  • Dissanayake HU, Sutherland K, Phillips CL, Grunstein RR, Mihailidou AS, Cistulli PA. Comparative effects of CPAP and mandibular advancement splint therapy on blood pressure variability in moderate to severe obstructive sleep apnoea. Sleep Med. 2021 Apr;80:294-300. doi: 10.1016/j.sleep.2021.01.059. Epub 2021 Feb 3.

    PMID: 33610954BACKGROUND
  • Sun Y, Liu F, Zhang Y, Lu Y, Su Z, Ji H, Cheng Y, Song W, Hidru TH, Yang X, Jiang Y. The relationship of endothelial function and arterial stiffness with subclinical target organ damage in essential hypertension. J Clin Hypertens (Greenwich). 2022 Apr;24(4):418-429. doi: 10.1111/jch.14447. Epub 2022 Mar 3.

    PMID: 35238151BACKGROUND
  • Tatasciore A, Di Nicola M, Tommasi R, Santarelli F, Palombo C, Parati G, De Caterina R. From short-term blood pressure variability to atherosclerosis: Relative roles of vascular stiffness and endothelial dysfunction. J Clin Hypertens (Greenwich). 2020 Jul;22(7):1218-1227. doi: 10.1111/jch.13871. Epub 2020 Jul 8.

    PMID: 32639102BACKGROUND
  • Genovesi S, Giussani M, Orlando A, Lieti G, Viazzi F, Parati G. Relationship between endothelin and nitric oxide pathways in the onset and maintenance of hypertension in children and adolescents. Pediatr Nephrol. 2022 Mar;37(3):537-545. doi: 10.1007/s00467-021-05144-2. Epub 2021 Jun 3.

    PMID: 34085102BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Jing Xu, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

March 21, 2024

Record last verified: 2024-02

Locations