A proof of concept, single centre, monotherapy, dose-ranging trial to evaluate the efficacy and tolerability of CB0011 at 0,7.5, 15, 30 and 45mg in Obstructive Sleep Apnea.

Phase 1

Completed

• Conditions: Obstructive Sleep Apnea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12605000687695
• Lead Sponsor: Cypress Bioscience Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Subjects must have a current diagnosis of Obstructive Sleep Apnea, have an apnea-hypopnea index (AHI) of between 10-40 (using a strict definition of hypopnea), with a calculated BMI equal or less than 40 at the time of study entry.

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Obstructive Sleep Apnea as measured by the patient apnea hypopnea index score (AHI).[Parameters measured at baseline, week two, week four and week six (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.];Changes in Obstructive Sleep Apnea as measured by the respiratory disturbance index (RDI).[Parameters measured at baseline, week two, week four and week six (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.];Changes in Obstructive Sleep Apnea as measured by oxygen desaturation index (ODI).[Parameters measured at baseline, week two, week four and week six (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.]

Secondary Outcome Measures

Name	Time	Method
Changes in daytime sedation, sleep quality, mood, fatigue and weight.[Measured at baseline, week two, week four and week six.];Early termination and quality of life.[Measured at baseline and week six or early termination.]