NCT00641810

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

3.3 years

First QC Date

March 18, 2008

Last Update Submit

December 29, 2013

Conditions

Keywords

CaffeineSnoringSleep

Outcome Measures

Primary Outcomes (1)

  • Snoring

    4 weeks

Secondary Outcomes (1)

  • Sleep Quality

    4 weeks

Study Arms (1)

A

EXPERIMENTAL

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.

Behavioral: Caffeine reduction

Interventions

Reduction in daily caffeine consumption from usual amounts to none.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin Littenberg, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

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

Locations