Effect of Nasal Steroids in Snoring Intensity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ioannis Koutsourelakis, University of Athens
ClinicalTrials.gov Identifier:
NCT01849406
First received: April 14, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Snoring
Drug: nasal spray Budesonide
Drug: Nasal spray Normal Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Crossover Trial of the Effect of Nasal Steroids in Snoring Intensity

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • snoring intensity [ Time Frame: one week therapy ] [ Designated as safety issue: No ]
    Snoring intensity would be measured using a calibrated microphone-sound meter system


Secondary Outcome Measures:
  • snoring frequency [ Time Frame: one week therapy ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: April 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849406

Locations
Greece
Department of Critical Care Medicine, Evangelismos Hospital of Athens
Athens, Greece
Sponsors and Collaborators
Ioannis Koutsourelakis
Investigators
Principal Investigator: Ioannis Koutsourelakis, MD University of Athens
  More Information

Publications:
Responsible Party: Ioannis Koutsourelakis, MD, PhD, University of Athens
ClinicalTrials.gov Identifier: NCT01849406     History of Changes
Other Study ID Numbers: NASTER
Study First Received: April 14, 2013
Last Updated: September 12, 2013
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Budesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014