Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)

Not Applicable

Completed

• Conditions: Common Cold
• Interventions: Procedure: inhalation of warm air in a Finnish sauna; Procedure: inhalation of ambient air in a Finnish sauna

• Registration Number: NCT00552981
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions:

1. the inhalation of warm air for inducing a warming of the throat and

2. the inhalation of ambient air as control. As outcome the effect on symptoms and duration of the common cold will be assessed. The interventions will consist of visits with a duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be fully dressed.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-01
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• symptom duration between 2 and 24 hours
• at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever
• no usage of medication bought in a pharmacy
• informed consent

Exclusion Criteria

• fever >38.5°C
• systolic blood pressure below 100 mmHg or above 160 mmHg
• severe chronic disease, which makes study participation impossible
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	inhalation of warm air in a Finnish sauna	-
2	inhalation of ambient air in a Finnish sauna	-

Primary Outcome Measures

Name	Time	Method
Symptom Score for Common Cold	Area under the curve day 2 to 7

Secondary Outcome Measures

Name	Time	Method
Usage of medication against common cold	Day 1 to 7
generalized feeling ill on a numeric rating scale 0-10,	Day 1, 2, 3, 5 and 7
safety (adverse events and serious adverse events)	1 to 7 days

Trial Locations

Locations (1)

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center; 🇩🇪 Berlin, Germany