SildenafilNCT00893191
The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
An observational study of Sildenafil and Sleep Apnea, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. The aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Sildenafil, Sleep Apnea, Sexual Dysfunction
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 50 healthy males aged 40 - 65 years
Who may be able to join
- Age - 40-65 years
- BMI equal to or over 30
Who cannot join
- A known cardiorespiratory, liver or kidney disease
- Treatment with nitrates or alfa blockers
- Performed polysomnography in the past
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Asaf Harofeh Medical Center
Tsrifin, 70300
Isaac Shpirer, MD
Yoram I Siegel, MD
About this study
Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. The aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. In addition we wish to assess the effect of sildenafil on sleep-disordered breathing.
- Conditions
- Sildenafil, Sleep Apnea, Sexual Dysfunction, Obesity
- Medical subject headings
- Sleep Apnea Syndromes, Sexual Dysfunction, Physiological, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Treated with 50 mg of Sildenafil at night | |
| Placebo | Treated with placebo at night |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea hypopnea index after sildenafil vs. placebo
Measured: Hours
Secondary outcomes (1)
Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SildenafilStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893191
- Sponsor's protocol ID
- 39/09
- Status last verified
- May 2009
- First submitted
- 3 May 2009
- Last updated
- 5 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT00893191
- Acronym / sponsor ID
- 39/09
- Conditions
- Sildenafil, Sleep Apnea, Sexual Dysfunction, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- May 2009
- First posted
- 5 May 2009 (estimated)
- 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.
Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. The aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. In addition we wish to assess the effect of sildenafil on sleep-disordered breathing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | – | –Treated with 50 mg of Sildenafil at night |
| Placebo | – | –Treated with placebo at night |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 healthy males aged 40 - 65 years
Key inclusion criteria (2 listed)
- Age - 40-65 years
- BMI equal to or over 30
Key exclusion criteria (3 listed)
- A known cardiorespiratory, liver or kidney disease
- Treatment with nitrates or alfa blockers
- Performed polysomnography in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
apnea hypopnea index after sildenafil vs. placebo
Time frame: Hours
1 secondary outcome
Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo
Time frame: hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sildenafil and Sleep Apnea, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 May 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isaac Shpiree, MD (972-8-9779024, I_shpirer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea hypopnea index after sildenafil vs. placebo (time frame: Hours). 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 5 May 2009.