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Effect of Nasal Steroids in Snoring Intensity

Primary Purpose

Snoring

Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
nasal spray Budesonide
Nasal spray Normal Saline
Sponsored by
Ioannis Koutsourelakis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. every night snoring;
  2. no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids);
  3. no smoking for the last 6 months;
  4. no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and
  5. written informed consent from each patient.

Exclusion Criteria:

  1. duration of snoring less than 60 minutes during sleep study, and
  2. central apnoeas more than five percent of total apnoeas.

Sites / Locations

  • Department of Critical Care Medicine, Evangelismos Hospital of Athens

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nasal spray Budesonide

Nasal spray Normal Saline

Arm Description

one week therapy of nasal budesonide (twice per day)

one week therapy of nasal normal saline (twice per day)

Outcomes

Primary Outcome Measures

snoring intensity
Snoring intensity would be measured using a calibrated microphone-sound meter system

Secondary Outcome Measures

snoring frequency
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.

Full Information

First Posted
April 14, 2013
Last Updated
September 12, 2013
Sponsor
Ioannis Koutsourelakis
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1. Study Identification

Unique Protocol Identification Number
NCT01849406
Brief Title
Effect of Nasal Steroids in Snoring Intensity
Official Title
A Randomized Crossover Trial of the Effect of Nasal Steroids in Snoring Intensity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ioannis Koutsourelakis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Snoring intensity would be measured using a calibrated microphone-sound meter system. The 2 microphones will be suspended at a distance of 1 m approximately above the surface of the patient's bed. This arrangement allows a non-invasive measurement of snoring that simulates the distance between sleeping bed partners. Before every study the system would be acoustically calibrated using a reference noise produced by a noise generator (86 dB). The signal would be sent at a sampling rate of 12 KHz through an analogue-digital converter to a computer system for subsequent analysis. All digitized signals will be recorded in the hard disk of a personal computer. A noise analyzer (Praat; Boersma 2005) will be used for the intensity analysis of snoring sound (Boersma, 2005).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal spray Budesonide
Arm Type
Active Comparator
Arm Description
one week therapy of nasal budesonide (twice per day)
Arm Title
Nasal spray Normal Saline
Arm Type
Placebo Comparator
Arm Description
one week therapy of nasal normal saline (twice per day)
Intervention Type
Drug
Intervention Name(s)
nasal spray Budesonide
Other Intervention Name(s)
budesonide
Intervention Description
one week therapy of nasal budesonide twice per day
Intervention Type
Drug
Intervention Name(s)
Nasal spray Normal Saline
Other Intervention Name(s)
Normal saline
Intervention Description
one week therapy of nasal normal saline twice per day
Primary Outcome Measure Information:
Title
snoring intensity
Description
Snoring intensity would be measured using a calibrated microphone-sound meter system
Time Frame
one week therapy
Secondary Outcome Measure Information:
Title
snoring frequency
Description
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.
Time Frame
one week therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: every night snoring; no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids); no smoking for the last 6 months; no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and written informed consent from each patient. Exclusion Criteria: duration of snoring less than 60 minutes during sleep study, and central apnoeas more than five percent of total apnoeas.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Koutsourelakis, MD
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Critical Care Medicine, Evangelismos Hospital of Athens
City
Athens
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
19665907
Citation
Pevernagie D, Aarts RM, De Meyer M. The acoustics of snoring. Sleep Med Rev. 2010 Apr;14(2):131-44. doi: 10.1016/j.smrv.2009.06.002. Epub 2009 Aug 8.
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Effect of Nasal Steroids in Snoring Intensity

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