Effect of Nasal Steroids in Snoring Intensity

NCT01849406 | Completed Phase 1 DMC

• 1 other identifier: NASTER
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

• snoring intensity

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

  one week therapy

Secondary Outcomes (1)

• snoring frequency

  one week therapy

Study Arms (2)

Nasal spray Budesonide

ACTIVE COMPARATOR

one week therapy of nasal budesonide (twice per day)

Drug: nasal spray Budesonide

Nasal spray Normal Saline

PLACEBO COMPARATOR

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

Drug: Nasal spray Normal Saline

Interventions

nasal spray Budesonide DRUG

one week therapy of nasal budesonide twice per day

Also known as: budesonide

Nasal spray Budesonide

Nasal spray Normal Saline DRUG

one week therapy of nasal normal saline twice per day

Also known as: Normal saline

Nasal spray Normal Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ioannis Koutsourelakis: lead

Study Sites (1)

Department of Critical Care Medicine, Evangelismos Hospital of Athens

Athens, Greece

Location

Related Publications (1)

• 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.

  PMID: 19665907 BACKGROUND

MeSH Terms

Conditions

Snoring

Interventions

Budesonide; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ioannis Koutsourelakis, MD

  University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: May 8, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

GR (1)