Obstructive Sleep ApneaNCT06960746
Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response?
A study testing lifestyle changing plus CPAP and CPAP in people with Obstructive Sleep Apnea and Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea, Erectile Dysfunction, Metabolic Syndrome
- What is being tested?
- lifestyle changing plus CPAP and CPAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- moderate and severe obstructive sleep apnea
- erectile dysfunction (mild and moderate)
- metabolic syndrome men
Who cannot join
- cardiac patients
- psychiatric men
- autoimmune diseased men
- renal diseased men
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed MA Elfahl contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Official title: Effect of Addition of Changing Lifestyle to CPAP in OSA Males Who Suffer Metabolic Syndrome and Impotence
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
Read the 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)
- Being tested
- lifestyle changing plus CPAP, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Erectile Dysfunction, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle changing plus CPAPBehavioural
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
international index of erectile function (five-item Arabic version)
a questionnaire that will assess erectile function
Measured: it will be measured after 12 weeks
Secondary outcomes (11)
index of apnea and hypopnea
it will assess number of events of apnea and hypapnea during one-hour sleeping
Measured: It will be measured after 12 weeks
ration of oxygen desaturation per hour
it will assess ratio of oxygen desaturation
Measured: It will be measured after 12 weeks
Epworth sleepiness scale
it will assess daytime sleepiness
Measured: It will be measured after 12 weeks
body mass index
it will be measured on empty stomach
Measured: it will be measured after 12 weeks
neck circumference
it will be measured by a tape
Measured: It will be measured after 12 weeks
fasting glycemia
it will be assessed by blood glucose meter
Measured: It will be measured after 12 weeks
high density lipoprotein
it will be assessed in serum
Measured: It will be measured after 12 weeks
triglycerides
it will be assessed in serum
Measured: It will be measured after 12 weeks
systolic blood pressure
it will be measured by manual sphygmomanometer
Measured: It will be measured after 12 weeks
diastolic blood pressure
it will be measured by manual sphygmomanometer
Measured: It will be measured after 12 weeks
waist circumference
it will be assessed at the level of umbilicus
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start15 Apr 2025
- Primary completion5 Sep 2025 (estimated)
- Study completion5 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960746
- Sponsor's protocol ID
- IRB00014233-31
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Addition of Changing Lifestyle to CPAP in OSA Males Who Suffer Metabolic Syndrome and Impotence
- ClinicalTrials.gov ID
- NCT06960746
- Acronym / sponsor ID
- IRB00014233-31
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 5 Sep 2025 (estimated)
- Study completion
- 5 Sep 2025 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: lifestyle changing plus CPAP20 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. |
| control group | Active comparator | Other: CPAP20 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 |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- moderate and severe obstructive sleep apnea
- erectile dysfunction (mild and moderate)
- metabolic syndrome men
Key exclusion criteria (4 listed)
- cardiac patients
- psychiatric men
- autoimmune diseased men
- renal diseased men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle changing plus CPAP20 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. | Behavioural | study group |
| CPAP20 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 | Other | control group |
Primary outcome
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
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed MA Elfahl contact
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle changing plus CPAP and CPAP in people with Obstructive Sleep Apnea and Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
international index of erectile function (five-item Arabic version) (time frame: it will be measured after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.