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Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)

NCT ID: NCT00612157

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to assess the efficacy of Eszopiclone in improving short and intermediate-term compliance with continuous positive airway pressure (CPAP) in patients newly diagnosed with obstructive sleep apnea (OSA).

Detailed Description

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CPAP is the treatment of choice for patients with OSA. However, patients are frequently intolerant of this therapy initially. After continued use, tolerance is achieved. However, this initial discomfort or intolerance frequently leads to a patient-initiated discontinuation of therapy. It has been shown that CPAP use at 1 month predicts use at 6 months and 1 year. Patients who initially struggle with or are intolerant of CPAP frequently abandon therapy and are unlikely to use it long term. To prevent this, sleep physicians often prescribe short courses of sedatives to help improve initial tolerance and promote better compliance with therapy. However, the effectiveness of this practice has not been validated in a clinical trial. Compliance, in reference to this study is the willingness of the patients to follow the prescribed course of treatment.

Conditions

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Obstructive Sleep Apnea

Keywords

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Obstructive Sleep Apnea Continuous Positive Airway Pressure CPAP Compliance Non-benzodiazepine hypnotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OSA CPAP

Group Type ACTIVE_COMPARATOR

Eszopiclone

Intervention Type DRUG

Eszopiclone 3mg orally at bedtime for 14 nights

Placebo

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DRUG

Matching placebo

Interventions

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Eszopiclone

Eszopiclone 3mg orally at bedtime for 14 nights

Intervention Type DRUG

Placebo control

Matching placebo

Intervention Type DRUG

Other Intervention Names

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Lunesta

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* Newly diagnosed with OSA who are prescribed CPAP therapy

Exclusion Criteria

* Patients \< 18 years old
* Patients over 65 years
* Pregnant women
* Patients with chronic liver disease
* Patients who abuse alcohol
* Patients taking narcotics or using sedative-hypnotic agents such as Ambien, Klonopin or Benadryl
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role collaborator

Walter Reed Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Walter Reed Army Medical Center

Principal Investigators

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Christopher J Lettieri, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

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Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Lettieri CJ, Eliasson AH, Andrada T, Khramtsov A, Raphaelson M, Kristo DA. Obstructive sleep apnea syndrome: are we missing an at-risk population? J Clin Sleep Med. 2005 Oct 15;1(4):381-5.

Reference Type BACKGROUND
PMID: 17564406 (View on PubMed)

Quera-Salva MA, McCann C, Boudet J, Frisk M, Borderies P, Meyer P. Effects of zolpidem on sleep architecture, night time ventilation, daytime vigilance and performance in heavy snorers. Br J Clin Pharmacol. 1994 Jun;37(6):539-43. doi: 10.1111/j.1365-2125.1994.tb04301.x.

Reference Type BACKGROUND
PMID: 7917771 (View on PubMed)

Feinberg I, Maloney T, Campbell IG. Effects of hypnotics on the sleep EEG of healthy young adults: new data and psychopharmacologic implications. J Psychiatr Res. 2000 Nov-Dec;34(6):423-38. doi: 10.1016/s0022-3956(00)00038-8.

Reference Type BACKGROUND
PMID: 11165310 (View on PubMed)

Blois R, Gaillard JM, Attali P, Coquelin JP. Effect of zolpidem on sleep in healthy subjects: a placebo-controlled trial with polysomnographic recordings. Clin Ther. 1993 Sep-Oct;15(5):797-809.

Reference Type BACKGROUND
PMID: 8269446 (View on PubMed)

Ballester E, Badia JR, Hernandez L, Carrasco E, de Pablo J, Fornas C, Rodriguez-Roisin R, Montserrat JM. Evidence of the effectiveness of continuous positive airway pressure in the treatment of sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med. 1999 Feb;159(2):495-501. doi: 10.1164/ajrccm.159.2.9804061.

Reference Type BACKGROUND
PMID: 9927363 (View on PubMed)

Lettieri CJ, Shah AA, Holley AB, Kelly WF, Chang AS, Roop SA; CPAP Promotion and Prognosis-The Army Sleep Apnea Program Trial. Effects of a short course of eszopiclone on continuous positive airway pressure adherence: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):696-702. doi: 10.7326/0003-4819-151-10-200911170-00006.

Reference Type DERIVED
PMID: 19920270 (View on PubMed)

Other Identifiers

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WRAMC07-17022

Identifier Type: -

Identifier Source: org_study_id