Nasal Decongestion and Obstructive Sleep Apnea

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Does Nasal Decongestion Improve Obstructive Sleep Apnea ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630474
• Other study ID #: EK-825
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2008
• Last updated: December 21, 2009
• Start date: January 2004
• Est. completion date: April 2005

Study information

• Verified date: December 2009
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Rhinitis
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Switzerland	Pulmonary Division, University Hospital Zurich	Zurich
Switzerland	Pulmonary Division, University Hospital Zurich, Switzerland	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep related breathing disturbances sleep efficiency daytime sleepiness		at end of one week treatment	No