NCT00612157

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4

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

January 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

5 months

First QC Date

January 29, 2008

Last Update Submit

February 25, 2009

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaContinuous Positive Airway PressureCPAP ComplianceNon-benzodiazepine hypnotics

Outcome Measures

Primary Outcomes (2)

  • Short term CPAP Compliance

    3 months

  • Intermediate CPAP Compliance

    1 year

Secondary Outcomes (5)

  • Quality of Life Issue - Prostate Symptoms for men

    1 month, 3 months, 6 months, 9 months, 12 months

  • Quality of Life Issue - Erectile Dysfunction for men

    1 month, 3 months, 6 months, 9 months, 12 months

  • Quality of Life Issue - Sleepiness

    1 month, 3 months, 6 months, 9 months, 12 months

  • Quality of Life Issue - Fatigue

    1 month, 3 months, 6 months, 9 months, 12 months

  • Quality of Life Issue - Subjective Sleep Quality

    1 month, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

OSA CPAP

ACTIVE COMPARATOR
Drug: Eszopiclone

Placebo

PLACEBO COMPARATOR
Drug: Placebo control

Interventions

EszopicloneDRUG

Eszopiclone 3mg orally at bedtime for 14 nights

Also known as: Lunesta
OSA CPAP
Placebo controlDRUG

Matching placebo

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Related Publications (6)

  • 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.

    PMID: 17564406BACKGROUND

  • 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.

    PMID: 7917771BACKGROUND

  • 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.

    PMID: 11165310BACKGROUND

  • 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.

    PMID: 8269446BACKGROUND

  • 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.

    PMID: 9927363BACKGROUND

  • 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.

    PMID: 19920270DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPyridines

Study Officials

  • Christopher J Lettieri, MD

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 11, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

February 1, 2009

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

US(1)