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NCT01601509: NTD
Randomized Placebo-controlled Cross-over Trial of the Effect of Nasal Tramazoline With Dexamethasone in Obstructive Sleep Apnoea Patients
NA trial testing Nasal tramazoline with dexamethazone in Obstructive Sleep Apnea Syndrome in 23 participants. Completed in 1 May 2012.
1 May 2012
Quick facts
| Lead sponsor | University of Athens |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 1 April 2010 |
| Primary completion | 1 May 2012 |
| Estimated completion | 1 May 2012 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Nasal tramazoline with dexamethazone — full drug profile →
- Nasal placebo
Conditions studied
- Obstructive Sleep Apnea Syndrome — all drugs for Obstructive Sleep Apnea Syndrome →
Sponsor
University of Athens
Who can join
Adults 18 to 80, any sex, with Obstructive Sleep Apnea Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Apnoea-hypopnoea index
Time frame: up to 4 weeks
After baseline assessment and randomization first group will undergo a one-week therapy with nasal tramazoline-dexamethazone, while second group will undergo a one-week therapy with nasal placebo. The second assessment will take place at the end of one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next first group will undergo a one
Sponsor's own description
Nasal resistance presents considerable variations during night\[8\]. Additionally, Oral and oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas \[7\].The hypothesis that the present study aims to test is whether the pharmacological prevention of increased nasal resistance during night could alter breathing route pattern and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal resistance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01601509
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Obstructive Sleep Apnea Syndrome
Currently open trials in the same condition.
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Other University of Athens trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01601509 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Athens
- Last refreshed: 17 May 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01601509.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing