Nasal Decongestion and Obstructive Sleep Apnea

Overview

Whether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime performance.

Full Title of Study: “Does Nasal Decongestion Improve Obstructive Sleep Apnea ?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2005

Interventions

  • Drug: xylometazoline
    • xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril

Arms, Groups and Cohorts

  • Active Comparator: 1
    • nasal application of xylometazoline
  • Placebo Comparator: 2
    • nasal application of placebo

Clinical Trial Outcome Measures

Primary Measures

  • sleep related breathing disturbances sleep efficiency daytime sleepiness
    • Time Frame: at end of one week treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Obstructive sleep apnea syndrome (excessive sleepiness, apnea/hypopnea index >10/h)
  • Chronic nasal congestion (complaint of impaired nasal breathing that interfered with subjective sleep quality on at least 3 nights per week during at least the last 3 months)

Exclusion Criteria

  • Nasal surgery within the last 6 months
  • Current treatment with nasal decongestants or topical steroids
  • Sleep disorders other than obstructive sleep apnea
  • Internal medical or psychiatric disorders that interfered with sleep

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Konrad E. Bloch, Professor, MD, University Hospital Zurich, Switzerland
  • Overall Official(s)
    • Konrad E Bloch, MD, Study Chair, University Hospital, Z├╝rich

Citations Reporting on Results

Clarenbach CF, Kohler M, Senn O, Thurnheer R, Bloch KE. Does nasal decongestion improve obstructive sleep apnea? J Sleep Res. 2008 Dec;17(4):444-9. doi: 10.1111/j.1365-2869.2008.00667.x. Epub 2008 Aug 15.

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