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

Sponsor:	Walter Reed Army Medical Center
Collaborator:	Sunovion
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00612157

Purpose

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).

Condition	Intervention	Phase
Obstructive Sleep Apnea	Drug: Eszopiclone Drug: Placebo control	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

Short term CPAP Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Intermediate CPAP Compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life Issue - Prostate Symptoms for men [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Quality of Life Issue - Erectile Dysfunction for men [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Quality of Life Issue - Sleepiness [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Quality of Life Issue - Fatigue [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Quality of Life Issue - Subjective Sleep Quality [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	154
Study Start Date:	January 2008
Study Completion Date:	February 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: OSA CPAP	Drug: Eszopiclone Eszopiclone 3mg orally at bedtime for 14 nights Other Name: Lunesta
Placebo Comparator: Placebo	Drug: Placebo control Matching placebo

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612157

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Walter Reed Army Medical Center

Sunovion

Investigators

Principal Investigator:

Christopher J Lettieri, MD

Walter Reed Army Medical Center

More Information

Publications:

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.

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.

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.

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.

Ballester E, Badia JR, Hernández 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. Erratum in: Am J Respir Crit Care Med 1999 May;159(5 Pt 1):1688.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Christopher J. Lettieri, MD / Pulmonary, Critical Care & Sleep Medicine, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00612157 History of Changes
Other Study ID Numbers:	WRAMC07-17022
Study First Received:	January 29, 2008
Last Updated:	February 25, 2009
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

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

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012