The Effect of Sleep Apnea and Hypertension on Gut Microbiome

NCT05266131 | Completed

• 1 other identifier: 2018-02
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) and hypertension are closely associated diseases. Here we characterized the differences in the gut microbiome which is affected by the two diseases, when the two diseases coexist or are present alone. Fifty-two consecutive patients who underwent polysomnography (PSG) were enrolled and divided into four groups: without OSA or hypertension (OSA0HT0), OSA without hypertension (OSA1HT0), hypertension without OSA (OSA0HT1), and with OSA and hypertension (OSA1HT1). Fecal specimens were collected for 16S rRNA sequencing and the characteristics of community richness, diversity, and composition of the gut microbiome and their relationship with disease were analyzed using bioinformatics methods.

Conditions

Obstructive Sleep Apnea; Hypertension; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• 1. Comparisons of the relative community richness of Clostridia of the gut microbiota in OSA0HT0,OSA0HT1,OSA1HT0 and OSA1HT1 group.

  from July 2017 to November 2017

Secondary Outcomes (3)

• 2. Comparison of the overall community diversity of the gut microbiome in OSA0HT0,OSA0HT1,OSA1HT0 and OSA1H1 group.

  from July 2017 to November 2017

• 3. Comparison of the overall community richness of the gut microbiome in OSA0HT0,OSA0HT1,OSA1HT0 and OSA1H1 group.

  from July 2017 to November 2017

• 4. Relationship between alpha diversity of the gut microbiome and hypoxia burden of PSG study.

  from July 2017 to November 2017

Study Arms (4)

OSA0HT0

without OSA or hypertension (OSA0HT0)

OSA1HT0

OSA without hypertension (OSA1HT0)

OSA0HT1

hypertension without OSA (OSA0HT1)

OSA1HT1

with OSA and hypertension (OSA1HT1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were divided into four groups according to whether they had a confirmed diagnosis of essential HT and OSA (AHI ≥15 beats/h (International Classification of Sleep Disorders (3rd edition) ), as follows. Individuals without OSA and HT belonged to group OSA0HT0; individuals with both OSA and HT were in group OSA1HT1; individuals without OSA but with HT were in group OSA0HT1; and individuals with OSA but without HT were in the group OSA1HT0.

You may qualify if:

• age 18 years or older
• outpatients and inpatients who underwent a PSG study for snoring
• those who volunteered for this study and signed an informed consent form

You may not qualify if:

• patients who were treated for OSA (regular CPAP therapy, oral appliances, maxillofacial surgery, etc.) prior to enrolment
• patients with secondary HT with a clear primary cause
• those with a history of dyspeptic disease (history of gastrointestinal surgery, peptic ulcer, inflammatory bowel disease, chronic pancreatitis, etc.)
• those who had organ insufficiency, were receiving immune agents or glucose
• those who had received antibiotic treatment in the last 2 months or had taken probiotic products (yogurt, milk, cheese, etc.) continuously (daily) for the last 2 months
• Alcohol or drug dependency

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 4, 2022
• Study Start: July 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: May 28, 2018
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)