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Nasal Decongestion and Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630474
First Posted: March 7, 2008
Last Update Posted: December 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Zurich
  Purpose
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.

Condition Intervention Phase
Obstructive Sleep Apnea Syndrome Rhinitis Drug: xylometazoline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Nasal Decongestion Improve Obstructive Sleep Apnea ?

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • sleep related breathing disturbances sleep efficiency daytime sleepiness [ Time Frame: at end of one week treatment ]

Enrollment: 12
Study Start Date: January 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
nasal application of xylometazoline
Drug: xylometazoline
xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
Other Name: Otrivin
Placebo Comparator: 2
nasal application of placebo
Drug: xylometazoline
xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
Other Name: Otrivin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630474


Locations
Switzerland
Pulmonary Division, University Hospital Zurich, Switzerland
Zurich, Switzerland, CH-8091
Pulmonary Division, University Hospital Zurich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
  More Information

Publications:
Responsible Party: Konrad E. Bloch, Professor, MD, University Hospital Zurich, Switzerland
ClinicalTrials.gov Identifier: NCT00630474     History of Changes
Other Study ID Numbers: EK-825
First Submitted: February 27, 2008
First Posted: March 7, 2008
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by University of Zurich:
sleep apnea, rhinitis

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Rhinitis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Xylometazoline
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents