Nasal Decongestion and Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00630474
First received: February 27, 2008
Last updated: December 21, 2009
Last verified: December 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 27, 2008
Last Updated: December 21, 2009
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University of Zurich:
sleep apnea, rhinitis

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

ClinicalTrials.gov processed this record on August 28, 2014