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

Walter Reed Army Medical Center

Status and phase

Completed

Phase 4

Conditions

Obstructive Sleep Apnea

Treatments

Drug: Placebo control

Drug: Eszopiclone

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

NCT00612157

WRAMC07-17022

Details and patient eligibility

About

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).

Full 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.

Enrollment

154 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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