Nasal Decongestion and Obstructive Sleep Apnea

December 21, 2009 updated by: University of Zurich

Does Nasal Decongestion Improve Obstructive Sleep Apnea ?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Pulmonary Division, University Hospital Zurich, Switzerland
      • Zurich, Switzerland, CH-8091
        • Pulmonary Division, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • Otrivin
PLACEBO_COMPARATOR: 2
nasal application of placebo
Drug: xylometazoline
xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
Other Names:
  • Otrivin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

April 1, 2005

Study Completion (ACTUAL)

April 1, 2005

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (ESTIMATE)

March 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 21, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-825

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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