The Effect of Caffeine Reduction on Snoring and Quality of Life

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Littenberg, University of Vermont
ClinicalTrials.gov Identifier:
NCT00641810
First received: March 18, 2008
Last updated: December 29, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Snoring
Behavioral: Caffeine reduction

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Caffeine Reduction on Snoring and Quality of Life

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Snoring [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep Quality [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Caffeine reduction
Reduction in daily caffeine consumption from usual amounts to none.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641810

Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Benjamin Littenberg, MD University of Vermont
  More Information

No publications provided

Responsible Party: Benjamin Littenberg, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT00641810     History of Changes
Other Study ID Numbers: 08-123
Study First Received: March 18, 2008
Last Updated: December 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Caffeine
Snoring
Sleep

Additional relevant MeSH terms:
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 29, 2014