Correlation Between CPAP Compliance and Food Intake Timing (TLMECC)

To Examine the Correlation Between Continuous Positive Airway Pressure (CPAP) and the Timing of Last Meal Before Bed Time.

Despite widespread agreement that continuous positive airway pressure is effective therapy for obstructive sleep apnea, it is estimated that 50% of patients recommended for therapy are noncompliant 1 year later. Nasal continuous positive airway pressure (CPAP) is the most definitive medical therapy for obstructive sleep apnea (OSA). Many patients have difficulty tolerating nasal CPAP due to nasal airway problems, mouth leak, and general discomfort from the mask and headgear. Interventions to improve compliance in such patients have not been studied. The investigators plan to further evaluate the usage of CPAP and identify if the timing of last meal before bedtime affects the compliance and tolerance of CPAP.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

Detailed Description

OSA is a chronic disorder characterized by frequent reduction and/or cessation of inspiratory airflow during sleep, with resulting hypoxemia and hypercapnia that are terminated by arousals. This pattern of repetitive arousals and nocturnal hypoxemia leads to disruption of sleep architecture and daytime hyper-somnolence as well as a multitude of neurobehavioral and cardiopulmonary derangements. All patients diagnosed with OSA should be instructed to undergo behavioral changes such as weight loss, avoidance of alcohol and sedatives, sleeping on the side and improvement in sleep hygiene, such as keeping a regular sleep schedule and getting an adequate amount of sleep. Continuous Positive Airways Pressure (CPAP) is currently considered to be the cornerstone of therapy for sleep apnea (OSA). However compliance with this treatment is frequently poor, which may lead to ongoing symptoms of sleep disruption, daytime sleepiness and poor waking cognitive function. Mechanical and psychological/educational interventions have been proposed to try to increase the hours of use of CPAP therapy. In older male patients with OSA, compliance with CPAP therapy is associated with attendance at a patient CPAP education and support group. Resolution of symptoms with therapy also appears to be associated with enhanced compliance. Some studies suggest that there is no direct causal relationship between OSA and gastro esophageal reflux disease (GERD). The investigators hypothesize that the compliance and tolerance to CPAP is affected with the timing of last meal before bedtime and this may also affect the symptoms of GERD.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in the HUMC who are diagnosed with sleep apnea will be determined through screening charts.

Description

Inclusion Criteria:

• Patients diagnosed with Obstructive Sleep Apnea.
• Patients on CPAP therapy
• Patients older than 21 years

Exclusion Criteria:

-Patients not on CPAP therapy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Continuous Positive Airway Pressure (CPAP) and the timing of last meal before bed time	Questionnaires will be used to determine correlation	12 months

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Investigators: Principal Investigator: Susan Zafarlotfi, PhD, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 10, 2013
• First Posted (ESTIMATE): May 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 2, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: OSA
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: Pro00000359