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

Cairo University (CU)

Status: Enrolling

Conditions: Erectile Dysfunction; Metabolic Syndrome; Obstructive Sleep Apnea

Treatments: Behavioral: lifestyle changing plus CPAP; Other: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06960746

IRB00014233-31

Details and patient eligibility

About

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

Full 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)

Enrollment: 40 estimated patients

Sex: Male

Ages: 40 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

study group

Experimental group

Description:

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.

Treatment:

Behavioral: lifestyle changing plus CPAP

control group

Active Comparator group

Description:

20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be included this control group. in this group CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks

Treatment:

Other: CPAP