The Effect of Caffeine Reduction on Snoring and Quality of Life

NCT ID: NCT00641810

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-06-30

Brief 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.

Conditions

Snoring

Keywords

Caffeine; Snoring; Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

After one week at usual levels of caffeine use, patients are asked to reduce their caffeine consumption to no more than 2 cups of coffee (or equivalent) for one week and then to zero for two weeks.

Group Type: EXPERIMENTAL

Caffeine reduction

Intervention Type: BEHAVIORAL

Reduction in daily caffeine consumption from usual amounts to none.

Interventions

Caffeine reduction

Reduction in daily caffeine consumption from usual amounts to none.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Littenberg

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Littenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont

Burlington, Vermont, United States

Countries

United States

Other Identifiers

08-123

Identifier Type: -

Identifier Source: org_study_id