Effect of Nasal Steroids in Snoring Intensity
Condition: Snoring
MeSH terms: Snoring
Study type: Interventional
Phase: Phase 1

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).
    

Intervention name(s): nasal spray Budesonide; Nasal spray Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): one week therapy of nasal budesonide twice per day; one week therapy of nasal normal saline twice per day
Other intervention name(s): budesonide; Normal saline
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment