Benign Prostate Hypertrophy(BPH), Obstructive Sleep Apnea( OSA)NCT07058038
Nocturnal Hypoxemia and Benign Prostatic Hyperplasia in OSA Patients
An observational study of Benign Prostate Hypertrophy(BPH), Obstructive Sleep Apnea( OSA), run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH), Obstructive Sleep Apnea( OSA)
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: patients who visited Mansoura University Hospitals sleep clinic for an initial evaluation and having symptoms consistent with sleep apnea
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura faculty of medicine
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: 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
Read the detailed description
All patients enrolled in the study underwent the following assessment:
- 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
- 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
- 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.
- 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)
- 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).
- 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
- Keywords
- nocturnal hypoxemia- OSA-BPH
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between sleep related Hypoxemia and Benign Prostatic hyperplasia in Patients with OSA
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
Measured: 13 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 May 2023
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate Hypertrophy(BPH), Obstructive Sleep Apnea( OSA)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058038
- Sponsor's protocol ID
- BPH in OSA patients
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang JF, Shen N, Zhao JM, Chen ML, Wang BY, Chen GP. Relationship between severity of obstructive sleep apnea and benign prostatic hyperplasia. Sleep Breath. 2023 Mar;27(1):363-369. doi: 10.1007/s11325-022-02617-y. Epub 2022 Apr 23.
PubMed 35460050
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Nocturnal Hypoxemia and Benign Prostatic Hyperplasia in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07058038
- Acronym / sponsor ID
- BPH in OSA patients
- Keywords
- nocturnal hypoxemia- OSA-BPH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Detailed description
All patients enrolled in the study underwent the following assessment:
- 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
- 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
- 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.
- 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)
- 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).
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- patients who visited Mansoura University Hospitals sleep clinic for an initial evaluation and having symptoms consistent with sleep apnea
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 35460050Huang JF, Shen N, Zhao JM, Chen ML, Wang BY, Chen GP. Relationship between severity of obstructive sleep apnea and benign prostatic hyperplasia. Sleep Breath. 2023 Mar;27(1):363-369. doi: 10.1007/s11325-022-02617-y. Epub 2022 Apr 23.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Hypertrophy(BPH), Obstructive Sleep Apnea( OSA), run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between sleep related Hypoxemia and Benign Prostatic hyperplasia in Patients with OSA (time frame: 13 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07058038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.