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Nasal Decongestion and Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea Syndrome, Rhinitis

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
xylometazoline
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring sleep apnea, rhinitis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Division, University Hospital Zurich, Switzerland
  • Pulmonary Division, University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

nasal application of xylometazoline

nasal application of placebo

Outcomes

Primary Outcome Measures

sleep related breathing disturbances sleep efficiency daytime sleepiness

Secondary Outcome Measures

Full Information

First Posted
February 27, 2008
Last Updated
December 21, 2009
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00630474
Brief Title
Nasal Decongestion and Obstructive Sleep Apnea
Official Title
Does Nasal Decongestion Improve Obstructive Sleep Apnea ?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Rhinitis
Keywords
sleep apnea, rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
nasal application of xylometazoline
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
nasal application of placebo
Intervention Type
Drug
Intervention Name(s)
xylometazoline
Other Intervention Name(s)
Otrivin
Intervention Description
xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
Primary Outcome Measure Information:
Title
sleep related breathing disturbances sleep efficiency daytime sleepiness
Time Frame
at end of one week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Chair
Facility Information:
Facility Name
Pulmonary Division, University Hospital Zurich, Switzerland
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Pulmonary Division, University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18710420
Citation
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.
Results Reference
result

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Nasal Decongestion and Obstructive Sleep Apnea

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