Effect of Nasal Steroids in Snoring Intensity

A Randomized Crossover Trial of the 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.

Study Overview

• Status: Completed
• Conditions: Snoring
• Intervention / Treatment: Drug: nasal spray Budesonide; Drug: Nasal spray Normal Saline

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Department of Critical Care Medicine, Evangelismos Hospital of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
snoring intensity	Snoring intensity would be measured using a calibrated microphone-sound meter system	one week therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one week therapy

Collaborators and Investigators

• Sponsor: Ioannis Koutsourelakis
• Investigators: Principal Investigator: Ioannis Koutsourelakis, MD, University of Athens

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 14, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Estimate): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: NASTER