Obstructive Sleep Apnea SyndromePhase 4NCT00630474
Nasal Decongestion and Obstructive Sleep Apnea
A Phase 4 study testing xylometazoline in people with Obstructive Sleep Apnea Syndrome and Rhinitis, run by University of Zurich at 2 sites in Switzerland.
Trial summary
Whether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Rhinitis
- What is being tested?
- xylometazoline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2004to Apr 2005
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obstructive sleep apnea syndrome (excessive sleepiness, apnea/hypopnea index >10/h)
- Chronic nasal congestion (complaint of impaired nasal breathing that interfered with subjective sleep quality on at least 3 nights per week during at least the last 3 months)
Who cannot join
- Nasal surgery within the last 6 months
- Current treatment with nasal decongestants or topical steroids
- Sleep disorders other than obstructive sleep apnea
- Internal medical or psychiatric disorders that interfered with sleep
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Pulmonary Division, University Hospital Zurich, Switzerland
Zurich, CH-8091
Pulmonary Division, University Hospital Zurich
Zurich, CH-8091
About this study
Official title: Does Nasal Decongestion Improve Obstructive Sleep Apnea ?
Whether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime performance.
- Conditions
- Obstructive Sleep Apnea Syndrome, Rhinitis
- Being tested
- xylometazoline
- Keywords
- sleep apnea, rhinitis
- Medical subject headings
- Sleep Apnea, Obstructive, Rhinitis, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylometazolineDrug
Also called Otrivin
xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | nasal application of xylometazoline Receives: Drug: xylometazoline |
| 2 | Placebo comparator | nasal application of placebo Receives: Drug: xylometazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep related breathing disturbances sleep efficiency daytime sleepiness
Measured: at end of one week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Konrad E Bloch, MD, Study chair, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630474
- Sponsor's protocol ID
- EK-825
- Status last verified
- Dec 2009
- First submitted
- 27 Feb 2008
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Clarenbach CF, Kohler M, Senn O, Thurnheer R, Bloch KE. Does nasal decongestion improve obstructive sleep apnea? J Sleep Res. 2008 Dec;17(4):444-9. doi: 10.1111/j.1365-2869.2008.00667.x. Epub 2008 Aug 15.
PubMed 18710420
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nasal Decongestion Improve Obstructive Sleep Apnea ?
- ClinicalTrials.gov ID
- NCT00630474
- Acronym / sponsor ID
- EK-825
- Conditions
- Obstructive Sleep Apnea Syndrome, Rhinitis
- Keywords
- sleep apnea, rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 7 Mar 2008 (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.
Whether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: xylometazolinenasal application of xylometazoline |
| 2 | Placebo comparator | Drug: xylometazolinenasal application of placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obstructive sleep apnea syndrome (excessive sleepiness, apnea/hypopnea index >10/h)
- Chronic nasal congestion (complaint of impaired nasal breathing that interfered with subjective sleep quality on at least 3 nights per week during at least the last 3 months)
Key exclusion criteria (4 listed)
- Nasal surgery within the last 6 months
- Current treatment with nasal decongestants or topical steroids
- Sleep disorders other than obstructive sleep apnea
- Internal medical or psychiatric disorders that interfered with sleep
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 |
|---|---|---|
| xylometazolineAlso: Otrivinxylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril | Drug | 1, 2 |
Primary outcome
sleep related breathing disturbances sleep efficiency daytime sleepiness
Time frame: at end of one week treatment
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 23 Dec 2009.
- Results publication: PubMed 18710420Clarenbach CF, Kohler M, Senn O, Thurnheer R, Bloch KE. Does nasal decongestion improve obstructive sleep apnea? J Sleep Res. 2008 Dec;17(4):444-9. doi: 10.1111/j.1365-2869.2008.00667.x. Epub 2008 Aug 15.
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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.
Konrad E Bloch, MD study chair
University Hospital, Zürich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing xylometazoline in people with Obstructive Sleep Apnea Syndrome and Rhinitis, run by University of Zurich at 2 sites in Switzerland.
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 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: finished, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
sleep related breathing disturbances sleep efficiency daytime sleepiness (time frame: at end of one week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630474, which also lists 1 linked publication.
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 23 Dec 2009.