Nasal Decongestion and Obstructive Sleep Apnea | NCT00630474

Studies
Nasal Decongestion and Obstructive Sleep Apnea

NCT00630474

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Dec 23, 2009Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

Obstructive Sleep Apnea Syndrome
Rhinitis

Interventions

xylometazoline

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Apr 2005Actual

Completion Date

Apr 2005Actual

First Submitted Date

Feb 27, 2008

First Submission Date that Met QC Criteria

Mar 6, 2008

First Posted Date

Mar 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2009

Last Update Posted Date

Dec 23, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	nasal application of xylometazoline	Drug: xylometazoline
2	Placebo Comparator	nasal application of placebo	Drug: xylometazoline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
xylometazoline	Drug	xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sleep related breathing disturbances sleep efficiency daytime sleepiness		at end of one week treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konrad E Bloch, MD	University Hospital, Zürich	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Division, University Hospital Zurich, Switzerland		Zurich		CH-8091	Switzerland
Pulmonary Division, University Hospital Zurich

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18710420	Result	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.

ID	Term
D020181	Sleep Apnea, Obstructive
D012220	Rhinitis
D012891	Sleep Apnea Syndromes

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic