NCT06960746

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 29, 2025

Last Update Submit

April 29, 2025

Conditions

Obstructive Sleep ApneaErectile DysfunctionMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

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

    a questionnaire that will assess erectile function

    it will be measured after 12 weeks

Secondary Outcomes (11)

  • index of apnea and hypopnea

    It will be measured after 12 weeks

  • ration of oxygen desaturation per hour

    It will be measured after 12 weeks

  • Epworth sleepiness scale

    It will be measured after 12 weeks

  • body mass index

    it will be measured after 12 weeks

  • neck circumference

    It will be measured after 12 weeks

  • +6 more secondary outcomes

Study Arms (2)

study group

EXPERIMENTAL

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.

Behavioral: lifestyle changing plus CPAP

control group

ACTIVE COMPARATOR

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

Other: CPAP

Interventions

lifestyle changing plus CPAPBEHAVIORAL

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.

study group
CPAPOTHER

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

control group

Eligibility Criteria

Age40 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveErectile DysfunctionMetabolic Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

Ahmed MA Elfahl

CONTACT

ahmedelfahl2021@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

April 15, 2025

Primary Completion

September 5, 2025

Study Completion

September 5, 2025

Last Updated

May 7, 2025

Record last verified: 2025-04

Locations

EG(1)