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NCT Number: NCT06960746

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

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Erectile Dysfunction Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Male Urogenital Diseases Mental Disorders Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases

Age range

40 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle changing plus CPAP

Behavioral

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.

CPAP

Other

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 outcomes

  1. international index of erectile function (five-item Arabic version)

    Time frame: it will be measured after 12 weeks

    a questionnaire that will assess erectile function

Secondary outcomes

  1. index of apnea and hypopnea

    Time frame: It will be measured after 12 weeks

    it will assess number of events of apnea and hypapnea during one-hour sleeping

  2. ration of oxygen desaturation per hour

    Time frame: It will be measured after 12 weeks

    it will assess ratio of oxygen desaturation

  3. Epworth sleepiness scale

    Time frame: It will be measured after 12 weeks

    it will assess daytime sleepiness

  4. body mass index

    Time frame: it will be measured after 12 weeks

    it will be measured on empty stomach

  5. neck circumference

    Time frame: It will be measured after 12 weeks

    it will be measured by a tape

  6. fasting glycemia

    Time frame: It will be measured after 12 weeks

    it will be assessed by blood glucose meter

  7. high density lipoprotein

    Time frame: It will be measured after 12 weeks

    it will be assessed in serum

  8. triglycerides

    Time frame: It will be measured after 12 weeks

    it will be assessed in serum

  9. systolic blood pressure

    Time frame: It will be measured after 12 weeks

    it will be measured by manual sphygmomanometer

  10. diastolic blood pressure

    Time frame: It will be measured after 12 weeks

    it will be measured by manual sphygmomanometer

  11. waist circumference

    Time frame: It will be measured after 12 weeks

    it will be assessed at the level of umbilicus

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed MA Elfahl

CONTACT

[email protected]

Ali MA Ismail, lecturer

CONTACT

[email protected]

01005154209

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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