The effect of morphine on obstructive sleep apnea

Phase 3

Completed

• Conditions: Obstructive sleep apnea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12613000858796
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-02
• Study Completion: 2015-08-21
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Men aged between 18-65 years; BMI < 40 kg/m2; awake SpO2>90%
- Screening PSG: OSA patients: AHI >= 5, SpO2 nadir >= 60%.

Exclusion Criteria

- Do not meet the inclusion criteria listed above or unwilling to follow the study protocol. - Shift workers and/or patients with other significant sleep disorders such as PLMS. - Severe medical and/or psychiatric diseases other than sleep aponea. - History of drug abuse and/or urine drug test positive to narcotic or other illicit drugs and/or history of allergy to morphine. - Subjects with current physical complaints (eg. respiratory infections or rhinitis) will not be included until symptoms are clear for 4 weeks. - Certain concomitant CNS active drug use such as hypno-sedatives and antipsychotics. Antidepressants will not be a specific exclusion criteria. - Creatinine clearance (Cockroft-Gault) < 60 ml/min; LFTs > 2x ULN. - Patients with a known history of CO2 retention (PCO2>45mmHg during wakefulness).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep time with SpO2 (oxygen) <90% (T90). This is calculated by measuring the amount of time that the oxygen levels fall below 90% during overnight polysomnography (sleep study) <br>[Total amount of time (minutes) oxygen levels fall below 90% during each overnight study]