Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

Women left out

• No kidney or liver problems

  Women with kidney or liver problems were turned away.

  “…docrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol.”

• No heart disease

  Women with heart disease, heart rhythm problems or a past heart attack were turned away.

  “…rum bilirubin (more than 1.5 times the upper limit of normal), or pre-trial ECG results demonstrating clinically significant arrhythmias, greater than a first degree AV block or a history of myocardial infarction within the last six months.”

• No seizures

  Women with epilepsy or past seizures were turned away.

  “…ihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the start of the study. Patients taking anticonvulsants are not eligible to participate even if they are willing to washout anticonvulsants for the trial.”

• No mental health conditions

  Women with depression, bipolar disorder or other mental health conditions were turned away.

  “Have psychiatric disorders, major affective or psychotic disorders, or other problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subj…”

Study titles and rules are shown in their original English.