Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA CPAP | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | Eszopiclone 3mg orally at bedtime for 14 nights |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short term CPAP Compliance | 3 months | |
| Intermediate CPAP Compliance | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher J Lettieri, MD | Walter Reed Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17564406 | Background | 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. | |
| 7917771 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo control | Drug | Matching placebo |
|
| 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 |
| 11165310 | Background | 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. |
| 8269446 | Background | 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. |
| 9927363 | Background | 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. |
| 19920270 | Derived | 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. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011725 |
| Pyridines |