| January 29, 2008 |
| February 25, 2009 |
| January 2008 |
| June 2008 (final data collection date for primary outcome measure) |
- 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 ]
|
| Same as current |
| Complete list of historical versions of study NCT00612157 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP) |
| Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance |
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). |
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. |
| Phase IV |
| Interventional |
| Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Obstructive Sleep Apnea |
- Drug: Eszopiclone
- Drug: Placebo control
|
| |
- 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.
|
| |
| Completed |
| 154 |
| February 2009 |
| June 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 64 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00612157 |
| Christopher J. Lettieri, MD / Pulmonary, Critical Care & Sleep Medicine, Walter Reed Army Medical Center |
| WRAMC07-17022 |
| Walter Reed Army Medical Center |
| Sepracor, Inc. |
| Principal Investigator: |
Christopher J Lettieri, MD |
Walter Reed Army Medical Center |
|
|
| Walter Reed Army Medical Center |
| February 2009 |