Nocturnal Hypoxemia and Benign Prostatic Hyperplasia in OSA Patients

July 8, 2025 updated by: Mansoura University

Association of Nocturnal Hypoxemia and Benign Prostatic Hyperplasia in Patients With Obstructive Sleep Apnea

  • Obstructive Sleep apnea (OSA) is a common sleep disorder characterized by frequent partial or complete obstructions of the upper airway during sleep leading to sleep fragmentation and sympathetic activation.
  • The main pathophysiological findings in OSAS are due to both a dynamic obstruction of the upper airway and the fragmentation of sleep during the night. These issues result in abnormal cycles of hypoxia and re-oxygenation. This disturbance produces transient ischemia of the tissues, a concept known as chronic intermittent hypoxia (CIH) with clinical implication in several cardiometabolic diseases
  • Polysomnography (PSG) is considered to be the gold standard for diagnosing sleep-related breathing disorders, which include obstructive sleep apnea (OSA), central sleep apnea, sleep-related hypoventilation disorders, and sleep related hypoxia disorder
  • Benign prostate hyperplasia (BPH) is the most frequent benign neoplasm in aging men and one of the most common chronic conditions in the male population.
  • Although the pathogenesis of BPH is not yet fully understood, recent evidence indicates the role of chronic inflammation in BPH, CIH which occurred in OSA patient induces systemic inflammatory processes; such chronic inflammatory conditions may contribute to tissue injury, activate cytokines release, increase the concentration of growth factors, and subsequently cause the development of BPH.
  • To date, little research has focused on the relationship between OSA and BPH, especially the impact of nocturnal hypoxemia , sleep architecture ,hormonal disturbance on BPH . Therefore, the aim of our study is to illuminate association between sleep related hypoxemia and BPH in Patients with OSA

Study Overview

Detailed Description

All patients enrolled in the study underwent the following assessment:

  1. Full History taking with stress on patient Complaint:

    Witnessed apneas during sleep. Awakening with choking or gasping sensation Loud habitual Snoring Dry mouth falling asleep during driving or motor vehicle Accidents Frequent nocturia Tiredness and Sleepiness in morning after sleep at night Awakening with a headache. Insomnia

  2. Clinical examination:

    - General examination: Respiratory rate, O2 saturation, blood pressure, heart rate, lower limb edema, neck vein, thyroid enlargement, any facial deformities.

    • Anthropometric measurements:

      • Height (in meters): patients stand up straight, with buttocks, shoulder blades, and heels touching the back of the stadiometer.

      • Weight (in kilograms)

      • Body mass index (BMI) is a quantitative metric used to estimate body fat based on an individual's weight relative to height. It is calculated by dividing body weight in kilograms by the square of height in meters (BMI = weight (kg) / height² (m²).
      • Neck circumference (NC) was measured between the mid-cervical point posteriorly and mid-anterior neck (below the laryngeal prominence). Measurements were taken while the participant was standing upright and looking straight ahead)
      • Waist circumference: circumferential measurement obtained at the level of the superior iliac crest.
    • Palatine tonsil size examination

      • Size 0 (a): no visible tonsillar tissue.

      • Size 1(b): tonsils are confined within the tonsillar pillars.

      • Size 2(c): tonsils extended to the level of the pillars.
      • Size 3(d): tonsils extended beyond the pillars.
      • Size 4(e): tonsils reach the midline
    • Friedman tongue position • FTP I: the uvula and tonsils (or pillar) are fully visible • FTP IIa: most of the uvula is visible, but the tonsils/pillar are obscured • FTP IIb: the entire soft palate is visible up to the base of the uvula.

      • FTP III: only the proximal portion of the soft palate is visible, the distal end is not seen.

      • FTP IV: only the hard palate is visible, neither the uvula nor the soft palate is seen

    • Local chest examination: To exclude accompanied pulmonary diseases
  3. Laboratory test

    • Complete blood count (CBC)

    • Arterial blood gases (ABG)

    • C-reactive protein (CRP).

    • Thyroid profile (TSH, T3, T4)
    • Lipid profile (Cholesterol, Triglyceride, LDL, HDL)
    • Urine analysis
    • PSA
    • Testosterone.
    • Serum Creatinine.
  4. Pelviabdominal us BPH was diagnosed when there is an increase in the volume of the prostate with a calculated volume exceeding 30 mL using the formula (width x height x length x 0.52)
  5. Scales & Questionnaires:

    All the questionnaires are written in English, but they were translated to Arabic for all patient and the cultural adaptation of the questions were considered.

    --Epworth sleepiness scale (ESS): The Epworth Sleepiness Scale (ESS) was used to assess the level of daytime sleepiness. In this questionnaire, participants rate their likelihood of falling asleep in various situations using a 4-point scale

    --Berlin Questionnaire: As part of the initial clinical assessment, the Berlin Questionnaire was administered to evaluate the risk of obstructive sleep apnea syndrome (OSAS). When possible, a family member or bed partner was consulted to confirm the accuracy of responses related to snoring behavior.

    --STOP-BANG score: The STOP-BANG questionnaire is one of the most widely accepted screening tools for obstructive sleep apnea (OSA).

    --International prostate symptom score: Lower urinary tract symptoms (LUTS) were assessed using the International Prostate Symptom Score (IPSS), a validated and widely used questionnaire designed to evaluate symptoms related to benign prostatic hyperplasia (BPH).

  6. Polysomnography All participants underwent overnight polysomnography using the (SONMO screen plus, SOMNO medics, Germany) . Recordings were performed according to the standard montage recommended by the American Academy of Sleep Medicine (AASM). Sleep studies were scored and interpreted manually in accordance with the AASM Scoring Manual, Version 3 .

    Measured variables:

    ***Measurement of the following physiologic variables is required during polysomnography (PSG) in accordance with the latest scoring criteria of the American Academy of Sleep Medicine (AASM, 2023)

    • Sleep staging

    • Airflow

    • Respiratory effort
    • Snoring
    • Oxygen saturation
    • Electrocardiogram
    • Limb movements
    • Body position

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Mansoura Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patients who visited Mansoura University Hospitals sleep clinic for an initial evaluation and having symptoms consistent with sleep apnea

Description

Inclusion criteria:

  • Males >18 years old with symptoms suggesting obstructive sleep apnea. Exclusion criteria
  • Chronic obstructive pulmonary diseases (COPD), interstitial lung disease (ILD), bronchial asthma (BA)
  • Heart failure, cerebral stroke, and other severe cerebrovascular and cardiovascular diseases.
  • Other sleep disorders, such as narcolepsy and restless leg syndrome, etc.
  • Mixed and Central sleep apnea.
  • Major mental or physical illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between sleep related Hypoxemia and Benign Prostatic hyperplasia in Patients with OSA
Time Frame: 13 month

sleep related hypoxemia can be assessed through parameters recorded during a diagnostic polysomnogram (PSG):

  • The oxygen desaturation index (ODI) : represents the number of times per hour of sleep that a patient's oxyhemoglobin saturation drops by more than a specified amount from baseline, typically 4%.
  • Mean SpO2 (%): The average oxygen saturation for the entire night.
  • T 90%: The percentage of total sleep time spent with oxygen saturation <90%.
  • Apnea hypopnea time % (AHT%): The percentage of total sleep time spent with apnea and hypopnea duration in patients with OSA
13 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

June 27, 2025

First Submitted That Met QC Criteria

July 8, 2025

First Posted (Actual)

July 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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