NCT00630474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

1.2 years

First QC Date

February 27, 2008

Last Update Submit

December 21, 2009

Conditions

Obstructive Sleep Apnea SyndromeRhinitis

Keywords

sleep apnea, rhinitis

Outcome Measures

Primary Outcomes (1)

  • sleep related breathing disturbances sleep efficiency daytime sleepiness

    at end of one week treatment

Study Arms (2)

1

ACTIVE COMPARATOR

nasal application of xylometazoline

Drug: xylometazoline

2

PLACEBO COMPARATOR

nasal application of placebo

Drug: xylometazoline

Interventions

xylometazolineDRUG

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

Also known as: Otrivin
12

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pulmonary Division, University Hospital Zurich, Switzerland

Zurich, CH-8091, Switzerland

Location

Pulmonary Division, University Hospital Zurich

Zurich, CH-8091, Switzerland

Location

Related 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.

    PMID: 18710420RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveRhinitisSleep Apnea Syndromes

Interventions

xylometazoline

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory Tract InfectionsInfectionsNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Konrad E Bloch, MD

    University Hospital, Zürich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

January 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

CH(2)