Obstructive Sleep ApneaTLMECCNCT01851811
Correlation Between CPAP Compliance and Food Intake Timing
An observational study of Obstructive Sleep Apnea, run by Hackensack Meridian Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the HUMC who are diagnosed with sleep apnea will be determined through screening charts.
Who may be able to join
- Patients diagnosed with Obstructive Sleep Apnea.
- Patients on CPAP therapy
- Patients older than 21 years
Who cannot join
- -Patients not on CPAP therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Continuous Positive Airway Pressure (CPAP) and the timing of last meal before bed time
Questionnaires will be used to determine correlation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Zafarlotfi, PhD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851811
- Sponsor's protocol ID
- Pro00000359
- Acronym
- TLMECC
- Status last verified
- Feb 2014
- First submitted
- 7 May 2013
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Examine the Correlation Between Continuous Positive Airway Pressure (CPAP) and the Timing of Last Meal Before Bed Time.
- ClinicalTrials.gov ID
- NCT01851811
- Acronym / sponsor ID
- TLMECC / Pro00000359
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the HUMC who are diagnosed with sleep apnea will be determined through screening charts.
Key inclusion criteria (3 listed)
- Patients diagnosed with Obstructive Sleep Apnea.
- Patients on CPAP therapy
- Patients older than 21 years
Key exclusion criteria (1 listed)
- -Patients not on CPAP therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Continuous Positive Airway Pressure (CPAP) and the timing of last meal before bed time
Time frame: 12 months
Questionnaires will be used to determine correlation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Zafarlotfi, PhD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Continuous Positive Airway Pressure (CPAP) and the timing of last meal before bed time (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.