Nasal Decongestion and Obstructive Sleep Apnea

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea Syndrome; Rhinitis
• Interventions: Drug: xylometazoline

• Registration Number: NCT00630474
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-21
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	xylometazoline	nasal application of xylometazoline
2	xylometazoline	nasal application of placebo

Primary Outcome Measures

Name	Time	Method
sleep related breathing disturbances sleep efficiency daytime sleepiness	at end of one week treatment

Trial Locations

Locations (2)

Pulmonary Division, University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Pulmonary Division, University Hospital Zurich, Switzerland; 🇨🇭 Zurich, Switzerland