Obstructive Sleep ApneaPhase 4NCT00100464
Serotonin and the Upper Airway in Obstructive Sleep Apnea
A Phase 4 study testing Paroxetine and 5HTP in people with Obstructive Sleep Apnea, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine if a certain medication, alone or combined with another medication, will increase muscle activity in the upper airway in people who do and people who do not have sleep apnea. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Paroxetine and 5HTP
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Dec 2003
- Phase
- Phase 4
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Group A: 20 Adult patients with mild to severe sleep apnea. If patients are being treated with nasal CPAP, they will continue treatment except on study nights.
Group B: 20 normal adult non-snoring subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcolm Randall VA Medical Center
Gainesville, Florida, 32608
About this study
The purpose of this study is to determine if a certain medication, alone or combined with another medication, will increase muscle activity in the upper airway in people who do and people who do not have sleep apnea. The medications being studied are paroxetine, a commonly used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary supplement without a prescription. Because the effects of paroxetine in previous studies were not very large, we will also study it combined with 5HTP to see if the effect on the upper airway muscles is greater.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Paroxetine, 5HTP
- Keywords
- Serotonin, Sleep Apnea Syndrome, Pharyngeal Muscles
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
5HTPDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2004 (estimated)
- Study startNov 2000
- Primary completionDec 2003
- Study completionDec 2003
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100464
- Sponsor's protocol ID
- RESP-013-98F
- Status last verified
- Sep 2013
- First submitted
- 30 Dec 2004
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin and the Upper Airway in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00100464
- Acronym / sponsor ID
- RESP-013-98F
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Serotonin, Sleep Apnea Syndrome, Pharyngeal Muscles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2000
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 31 Dec 2004 (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.
The purpose of this study is to determine if a certain medication, alone or combined with another medication, will increase muscle activity in the upper airway in people who do and people who do not have sleep apnea. The medications being studied are paroxetine, a commonly used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary supplement without a prescription. Because the effects of paroxetine in previous studies were not very large, we will also study it combined with 5HTP to see if the effect on the upper airway muscles is greater.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Paroxetine | Drug | – |
| 5HTP | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paroxetine and 5HTP in people with Obstructive Sleep Apnea, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Sep 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 17 Sep 2013.