NCT01851811

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

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

October 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

May 7, 2013

Last Update Submit

February 2, 2014

Conditions

Keywords

OSA

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients not on CPAP therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Susan Zafarlotfi, PhD

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 13, 2013

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations