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

Obstructive Sleep Apnea Clinical Trial

— CPAPASAP  

Official title:

Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612157
• Other study ID #: WRAMC07-17022
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2008
• Last updated: February 25, 2009
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: February 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Eszopiclone
Eszopiclone 3mg orally at bedtime for 14 nights
• Placebo control
Matching placebo

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center	Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term CPAP Compliance		3 months	No
Primary	Intermediate CPAP Compliance		1 year	No
Secondary	Quality of Life Issue - Prostate Symptoms for men		1 month, 3 months, 6 months, 9 months, 12 months	No
Secondary	Quality of Life Issue - Erectile Dysfunction for men		1 month, 3 months, 6 months, 9 months, 12 months	No
Secondary	Quality of Life Issue - Sleepiness		1 month, 3 months, 6 months, 9 months, 12 months	No
Secondary	Quality of Life Issue - Fatigue		1 month, 3 months, 6 months, 9 months, 12 months	No
Secondary	Quality of Life Issue - Subjective Sleep Quality		1 month, 3 months, 6 months, 9 months, 12 months	No