The Effect of Caffeine Reduction on Snoring and Quality of Life
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 31, 2013
December 1, 2013
3.3 years
March 18, 2008
December 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Snoring
4 weeks
Secondary Outcomes (1)
Sleep Quality
4 weeks
Study Arms (1)
A
EXPERIMENTALAfter 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Littenberg, MD
University of Vermont
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 31, 2013
Record last verified: 2013-12