Nasal Decongestion and Obstructive Sleep Apnea

NCT ID: NCT00630474

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome Rhinitis

Keywords

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sleep apnea, rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

nasal application of xylometazoline

Group Type ACTIVE_COMPARATOR

xylometazoline

Intervention Type DRUG

xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril

2

nasal application of placebo

Group Type PLACEBO_COMPARATOR

xylometazoline

Intervention Type DRUG

xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril

Interventions

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xylometazoline

xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril

Intervention Type DRUG

Other Intervention Names

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Otrivin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Zurich, Switzerland

Principal Investigators

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Konrad E Bloch, MD

Role: STUDY_CHAIR

University Hospital, Zürich

Locations

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Pulmonary Division, University Hospital Zurich, Switzerland

Zurich, , Switzerland

Site Status

Pulmonary Division, University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 18710420 (View on PubMed)

Other Identifiers

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EK-825

Identifier Type: -

Identifier Source: org_study_id