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Recruiting NCT06960746

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

No phase Interventional Obstructive Sleep Apnea Erectile Dysfunction Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lifestyle changing plus CPAP, CPAP.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Erectile Dysfunction, Metabolic Syndrome. Basic parameters: 40 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Addition of Changing Lifestyle to CPAP in OSA Males Who Suffer Metabolic Syndrome and Impotence

Overview

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)

Interventions

  • Behavioral lifestyle changing plus CPAP
    20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be in this 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 plus lifestyle changes that will contain 3-session per-week 40-minute treadmill exercising and low-caloric/dietary 12-week restriction.
  • Other CPAP
    20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be in this group. in this group CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks

Primary outcome measures

  • international index of erectile function (five-item Arabic version) [Time frame: it will be measured after 12 weeks]
Secondary outcome measures (11)
  • index of apnea and hypopnea [Time frame: It will be measured after 12 weeks]
  • ration of oxygen desaturation per hour [Time frame: It will be measured after 12 weeks]
  • Epworth sleepiness scale [Time frame: It will be measured after 12 weeks]
  • body mass index [Time frame: it will be measured after 12 weeks]
  • neck circumference [Time frame: It will be measured after 12 weeks]
  • fasting glycemia [Time frame: It will be measured after 12 weeks]
  • high density lipoprotein [Time frame: It will be measured after 12 weeks]
  • triglycerides [Time frame: It will be measured after 12 weeks]
  • systolic blood pressure [Time frame: It will be measured after 12 weeks]
  • diastolic blood pressure [Time frame: It will be measured after 12 weeks]
  • waist circumference [Time frame: It will be measured after 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of physical therapy — Giza

Identifiers

NCT: NCT06960746 · IRB00014233-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗