Correlation Between CPAP Compliance and Food Intake Timing

Obstructive Sleep Apnea Clinical Trial

— TLMECC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851811
• Other study ID #: Pro00000359
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: February 2, 2014
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2014
• Source: Hackensack University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No