Effect of Nasal Steroids in Snoring Intensity
It is anecdotally well known that patients snore more when their nose is blocked. However, the therapeutic effect of improving nasal airway patency on snoring indices remains a point of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and failed to show any improvement in the number of snores after its application, although apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that dilation of the anterior nares in patients without nasal pathology has a relatively weak effect on snoring, and routine use of nasal dilating appliances was not recommended for the treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep apnea (OSA) implying that there might be an equivalent result for the use of nasal steroids on snoring indices.
Additionally, the present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively have decreased nasal breathing epochs.
It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal steroids might also increase nasal breathing epochs and lead to decreased snoring indices in patients who had decreased nasal breathing before the administration of nasal steroids.
Patients will be randomized in two groups: the patients of the first group will undergo a one week therapy of nasal budesonide, then two weeks of washout period, and thereafter one week of nasal normal saline. The patients of the second group will undergo a one week therapy of nasal normal saline, then two weeks of washout period, and thereafter one week of nasal budesonide. Before and after each treatment regimen patients will undergo an assessment, which will consist of anterior rhinomanometry and polysomnography with concomitant measurement of snoring indices and breathing route pattern.
The investigators hypothesize that the application for one week of nasal budesonide has a beneficial effect on snoring indices in patients who present before the application decreased proportion of nasal breathing epochs and in whom nasal budesonide succeeded in increasing nasal breathing epochs.
|Snoring||Drug: nasal spray Budesonide Drug: Nasal spray Normal Saline||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Crossover Trial of the Effect of Nasal Steroids in Snoring Intensity|
- snoring intensity [ Time Frame: one week therapy ]Snoring intensity would be measured using a calibrated microphone-sound meter system
- snoring frequency [ Time Frame: one week therapy ]Before and after each treatment regimen patients will undergo an assessment, which will consist of anterior rhinomanometry and polysomnography with concomitant measurement of snoring indices and breathing route pattern.
|Study Start Date:||April 2013|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Nasal spray Budesonide
one week therapy of nasal budesonide (twice per day)
Drug: nasal spray Budesonide
one week therapy of nasal budesonide twice per day
Other Name: budesonide
Placebo Comparator: Nasal spray Normal Saline
one week therapy of nasal normal saline (twice per day)
Drug: Nasal spray Normal Saline
one week therapy of nasal normal saline twice per day
Other Name: Normal saline
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849406
|Department of Critical Care Medicine, Evangelismos Hospital of Athens|
|Principal Investigator:||Ioannis Koutsourelakis, MD||University of Athens|