Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response?

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea; Erectile Dysfunction; Metabolic Syndrome

• Registration Number: NCT06960746
• Lead Sponsor: Cairo University

Brief Summary

The problems like metabolic syndrome and sexual impotence in males with obstructive sleep apnea are common. continuous passive airway pressure (CPAP) is an authorized treatment for this type of apnea but still the recommendations of changing lifestyles are the suggested cornerstone therapies especially in obese males

Detailed Description

Forty males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be randomized to control group (CPAP will be applied in this group that will contain 20 males, CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks ) and study 20-patient group (also CPAP will be applied with the same protocol of control group plus lifestyle changes that will contain 3-session per-week 40-minute treadmill exercising and low-caloric/dietary 12-week restriction)

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-15
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-09-05
• Study Completion: 2025-09-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• moderate and severe obstructive sleep apnea
• erectile dysfunction (mild and moderate)
• metabolic syndrome men

Exclusion Criteria

• cardiac patients
• psychiatric men
• autoimmune diseased men
• renal diseased men

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
international index of erectile function (five-item Arabic version)	it will be measured after 12 weeks	a questionnaire that will assess erectile function

Secondary Outcome Measures

Name	Time	Method
index of apnea and hypopnea	It will be measured after 12 weeks	it will assess number of events of apnea and hypapnea during one-hour sleeping
ration of oxygen desaturation per hour	It will be measured after 12 weeks	it will assess ratio of oxygen desaturation
Epworth sleepiness scale	It will be measured after 12 weeks	it will assess daytime sleepiness
body mass index	it will be measured after 12 weeks	it will be measured on empty stomach
neck circumference	It will be measured after 12 weeks	it will be measured by a tape
fasting glycemia	It will be measured after 12 weeks	it will be assessed by blood glucose meter
high density lipoprotein	It will be measured after 12 weeks	it will be assessed in serum
triglycerides	It will be measured after 12 weeks	it will be assessed in serum
systolic blood pressure	It will be measured after 12 weeks	it will be measured by manual sphygmomanometer
diastolic blood pressure	It will be measured after 12 weeks	it will be measured by manual sphygmomanometer
waist circumference	It will be measured after 12 weeks	it will be assessed at the level of umbilicus

Trial Locations

Locations (1)

Faculty of physical therapy; 🇪🇬 Giza, Dokki, Egypt