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Nasal Decongestion and Obstructive Sleep Apnea

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.
ClinicalTrials.gov Identifier: NCT00630474
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Rhinitis Drug: xylometazoline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Nasal Decongestion Improve Obstructive Sleep Apnea ?
Study Start Date : January 2004
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

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 Posted: March 7, 2008    Key Record Dates
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