The Effect of Caffeine Reduction on Snoring and Quality of Life
Primary Purpose
Snoring
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine reduction
Sponsored by
About this trial
This is an interventional treatment trial for Snoring focused on measuring Caffeine, Snoring, Sleep
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.
Sites / Locations
- University of Vermont
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
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.
Outcomes
Primary Outcome Measures
Snoring
Secondary Outcome Measures
Sleep Quality
Full Information
NCT ID
NCT00641810
First Posted
March 18, 2008
Last Updated
December 29, 2013
Sponsor
University of Vermont
1. Study Identification
Unique Protocol Identification Number
NCT00641810
Brief Title
The Effect of Caffeine Reduction on Snoring and Quality of Life
Official Title
The Effect of Caffeine Reduction on Snoring and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
Keywords
Caffeine, Snoring, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caffeine reduction
Intervention Description
Reduction in daily caffeine consumption from usual amounts to none.
Primary Outcome Measure Information:
Title
Snoring
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sleep Quality
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Littenberg, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Caffeine Reduction on Snoring and Quality of Life
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