Blood Pressure and Obstructive Sleep Apnea

The Changes in Blood Pressure in Patients With Obstructive Sleep Apnea Following an Overnight Sleep

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.

Study Overview

• Status: Completed
• Conditions: The Effects of Obstructive Sleep Apnea on Blood Pressure Measurement
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Actual): 2037

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence

Description

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%

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure, before sleep and after awakening	Measurement of blood pressure at two time points: before sleep and after awakening	20:30 pm ~ 06:00 am next day

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): July 16, 2023

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2022-07-013CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No