The Effect of Caffeine Reduction on Snoring and Quality of Life

Snoring Clinical Trial

Official title:

The Effect of Caffeine Reduction on Snoring and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641810
• Other study ID #: 08-123
• Status: Completed
• Phase: N/A
• First received: March 18, 2008
• Last updated: December 29, 2013
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2013
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Snoring is a problem for many people, often disturbing energy level, quality of sleep, and the relationship with a bed partner. Two observational studies that have indicated a relationship between the consumption of caffeine and snoring. The objective of this study will be to observe the degree of snoring and quality of sleep when caffeine intake is reduced over a period of four weeks. This will be a prospective, before-and-after study of a behavioral intervention.

This study will engage thirty adults who report snoring, drink two cups of coffee or more per day (or an equivalent amount of caffeine), and have a consistent bed partner who can report on snoring severity. Both subject and partner will be asked to fill out a diary each day. The subjects will record the type of caffeine consumed, time at which each beverage was ingested, the total minutes of physical exercise, any caffeine withdrawal symptoms, quality of sleep, and energy in the morning. The partner (reporter) will rate his or her own sleep quality and energy in the morning, as well as the snoring level of the subject. Beginning the second week of the study, the subject will reduce caffeine intake to half the baseline consumption, and on the third week, will eliminate caffeine altogether.

At the end of each week, the participants will be asked to mail their diaries in to the researchers and start a new series of entries. The study team will also call each week to answer any questions or concerns of the subject and reporter, and encourage continued reporting. When six weeks have elapsed following the completion of the last diary, the investigators will make a final call to the participants to record their current level of snoring, quality of sleep, and daily energy level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age at least 18 years

• consume 16 ounces of coffee or 25 ounces of caffeinated soda or tea

• consistent bed partner willing to serve as reporter

• reported as a loud snorer (6 or more on 10 point scale) most days of an average week

Exclusion Criteria:

• pregnant

• diagnosed by doctor with sleep apnea, facial or airways defect

• any facial or airways surgery that has changed snoring pattern.

• upper airways infection that requires antibiotics, cough suppressants, etc. in the last month

• use any continuous positive airway pressure (CPAP) device or dental appliance

• bed partner hearing impairment or defects.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Snoring

Intervention

Behavioral:
• Caffeine reduction
Reduction in daily caffeine consumption from usual amounts to none.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Snoring		4 weeks	No
Secondary	Sleep Quality		4 weeks	No