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Blood Pressure and Obstructive Sleep Apnea

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Completed
CT.gov ID
NCT06027424
Collaborator
(none)
2,037
Enrollment
1
Location
8.6
Actual Duration (Months)
235.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and hypertension in a dose-response manner, independent of confounding variables such as age, smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). The relationship between AHI and changes of blood pressure deserves further investigation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Approximately 50% of patients with obstructive sleep apnea (OSA) have hypertension; up to 30% of patients with hypertension have OSA, and the prevalence is even higher in those of resistant hypertension. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). This retrospective study aimed to determine if OSA severity and AHI have effect on blood pressure measurements and the nocturnal changes following an overnight sleep.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2037 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Changes in Blood Pressure in Patients With Obstructive Sleep Apnea Following an Overnight Sleep
    Actual Study Start Date :
    Oct 26, 2022
    Actual Primary Completion Date :
    Feb 28, 2023
    Actual Study Completion Date :
    Jul 16, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Non-OSA

    AHI < 5 events/h (AHI, apnea-hypopnea index, the number of apneas and hypopneas per hour of total sleep time)
    Mild OSA

    5 events/h ≤ AHI < 15 events/h
    Moderate OSA

    15 events/h ≤ AHI < 30 events/h
    Severe OSA

    AHI ≥ 30 events/h

    Outcome Measures

    Primary Outcome Measures

    1. Blood pressure, before sleep and after awakening [20:30 pm ~ 06:00 am next day]

      Measurement of blood pressure at two time points: before sleep and after awakening

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    (1). Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence; (2). Feasibility to measure BP via wrist monitors; (3). Confirmation of wakefulness through electroencephalography.

    Exclusion Criteria:

    (1). Failure to measure BP via wrist monitors; (2). Age younger than 18 years; (3). Sleep efficiency less than 50%; (4). Central sleep apnea ≥ 50%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Veterans General Hospital Taipei Taiwan

    Sponsors and Collaborators

    • Taipei Veterans General Hospital, Taiwan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taipei Veterans General Hospital, Taiwan
    ClinicalTrials.gov Identifier:
    NCT06027424
    Other Study ID Numbers:
    • 2022-07-013CC
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive

    Study Results

    No Results Posted as of Sep 7, 2023