Actively Recruiting

Phase Not Applicable
Age: 40Years - 50Years
MALE
ID06960746

Effect of Adding Lifestyle Changes to CPAP in Males with Obstructive Sleep Apnea, Metabolic Syndrome, and Erectile Dysfunction

Led by Cairo University · Updated on 2025-05-07

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on males aged 40 to 50 who have metabolic syndrome, erectile dysfunction, and obstructive sleep apnea. The study aims to assess whether adding lifestyle changes to standard continuous positive airway pressure (CPAP) therapy can improve health outcomes. Lifestyle modification is considered important alongside CPAP, especially for obese males with these conditions. Participants are divided into two groups of 20 males each. Both groups receive CPAP therapy, which involves using a machine during sleep for 4 hours a night, five days a week, over 12 weeks. One group also participates in lifestyle changes including treadmill exercise sessions three times a week for 40 minutes and follows a low-calorie diet for 12 weeks. During the study, researchers will measure erectile function using an Arabic version of an international index after 12 weeks. They will also evaluate sleep apnea severity, oxygen levels during sleep, daytime sleepiness, body measurements like body mass index and neck circumference, blood sugar, cholesterol levels, blood pressure, and waist size. These assessments help monitor the effects of treatments and lifestyle changes over the 12-week period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 50Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male with moderate or severe obstructive sleep apnea
  • Mild or moderate erectile dysfunction
  • Diagnosis of metabolic syndrome
  • Age between 40 and 50 years
Not Eligible

You will not qualify if you...

  • Presence of heart disease
  • Presence of psychiatric conditions
  • Presence of autoimmune diseases
  • Presence of kidney disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive CPAP therapy five days weekly during night-sleeping for 4 hours for 12 weeks. Participants in the study group also attend three treadmill exercise sessions per week and follow a low-calorie dietary restriction for 12 weeks.

Weekly visits for up to 12 weeks

Trial Site Locations

Total: 1 location

1

Faculty of physical therapy

Giza, Dokki, Egypt

Actively Recruiting

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Research Team

A

Ali MA Ismail, lecturer

A

Ahmed MA Elfahl

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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