Sleep ApneaNCT00791674
Opiate Sleep Disordered Breathing Study
An observational study of Sleep Apnea, run by Adelaide Institute for Sleep Health at 2 sites in Australia.
Trial summary
Lay title: A study of breathing pauses during sleep in patients on long term opiates. Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals from the brain driving breathing (central… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea
- How many people
- 50 participants
- Where
- 2 sitesAustralia
- Study dates
- Dec 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pain clinic outpatients were contacted if they were on the specified doses (
Who may be able to join
- Patients on long acting Morphine >40mg/day, Oxycontin >30mg/day, and Methadone >20mg/day were contacted.
- Stable opiate dose for 2 weeks
- Lives within 80KM of FMC
Who cannot join
- Significant CCF/CVA
- Severe COPD
- Major Psychiatric illness
- History of substance abuse in the last 3 months
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
Pain Management Unit, Flinders Medical Centre
Bedford Park, South Australia, 5042
Dilip Kapur, FRCA, FANZCA, 61882045511, dilip.kapur@health.sa.gov.au
John Plummer, PhD, AStat
- Recruiting
Adelaide Institute of Sleep Health, Repatriation General Hospital,
Daw Park, South Australia, 5041
Anand R Rose, MD,FRACP
Nick Antic, PhD, FRACP
About this study
Official title: Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy
Lay title: A study of breathing pauses during sleep in patients on long term opiates.
Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals from the brain driving breathing (central sleep apnoea). Clinical observation has noticed that patients on opiates have an increase in sleep apnoea.
Hypothesis: This study looks at the relationship of opiates (when used for patients chronic pain) and the occurrence of sleep apnoea. It is expected that there will be an increase in sleep apnoea (particularly of the central variant) particularly in patients on long term opiates.
Read the detailed description
The purpose for this study is to test the hypothesis that sleep disordered breathing is more prevalent amongst a group of patients on high dose opiates for chronic pain.
Aims
- To define the prevalence of sleep disordered breathing in a group of patients on oral morphine for chronic pain.
- To determine the prevalence of respiratory failure in this cohort of patients. Patients on long term opiates (>6 months) from an outpatient pain clinic population on long acting morphine formulations > 40 mg/day, Oxycontin 30 mg/day, and Methadone > 20 mg/day were prospectively recruited. Home polysomnograms were done on them. During their clinical review they have spirometry, arterial blood gases, psychomotor vigilance tests done on them.
- Conditions
- Sleep Apnea
- Keywords
- Opiates, sleep apnea, ventilatory failure
- Medical subject headings
- Sleep Apnea Syndromes, Hypoventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disordered breathing in patients on long term opiates.
Measured: 18 months
Secondary outcomes (1)
Prevalence of ventilatory failure in this cohort
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adelaide Institute for Sleep Health
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders Medical Centre
- Investigators
- Anand R Rose, MD,FRACP, Principal investigator, Adelaide Institute of Sleep HealthDoug McEvoy, MD, FRACP, Study director, Adelaide Institute of Sleep Health, Repatriation General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791674
- Sponsor's protocol ID
- 50/07
- Status last verified
- Nov 2008
- First submitted
- 13 Nov 2008
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy
- ClinicalTrials.gov ID
- NCT00791674
- Acronym / sponsor ID
- 50/07
- Conditions
- Sleep Apnea
- Keywords
- Opiates, sleep apnea, ventilatory failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adelaide Institute for Sleep HealthUniversity, hospital or other
- Collaborators
- Flinders Medical Centre
- Study start
- Dec 2007
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lay title: A study of breathing pauses during sleep in patients on long term opiates.
Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals from the brain driving breathing (central sleep apnoea). Clinical observation has noticed that patients on opiates have an increase in sleep apnoea.
Hypothesis: This study looks at the relationship of opiates (when used for patients chronic pain) and the occurrence of sleep apnoea. It is expected that there will be an increase in sleep apnoea (particularly of the central variant) particularly in patients on long term opiates.
Detailed description
The purpose for this study is to test the hypothesis that sleep disordered breathing is more prevalent amongst a group of patients on high dose opiates for chronic pain.
Aims
- To define the prevalence of sleep disordered breathing in a group of patients on oral morphine for chronic pain.
- To determine the prevalence of respiratory failure in this cohort of patients. Patients on long term opiates (>6 months) from an outpatient pain clinic population on long acting morphine formulations > 40 mg/day, Oxycontin 30 mg/day, and Methadone > 20 mg/day were prospectively recruited. Home polysomnograms were done on them. During their clinical review they have spirometry, arterial blood gases, psychomotor vigilance tests done on them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pain clinic outpatients were contacted if they were on the specified doses (
Key inclusion criteria (3 listed)
- Patients on long acting Morphine >40mg/day, Oxycontin >30mg/day, and Methadone >20mg/day were contacted.
- Stable opiate dose for 2 weeks
- Lives within 80KM of FMC
Key exclusion criteria (4 listed)
- Significant CCF/CVA
- Severe COPD
- Major Psychiatric illness
- History of substance abuse in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of sleep disordered breathing in patients on long term opiates.
Time frame: 18 months
1 secondary outcome
Prevalence of ventilatory failure in this cohort
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand R Rose, MD,FRACP principal investigator
Adelaide Institute of Sleep Health
Doug McEvoy, MD, FRACP study director
Adelaide Institute of Sleep Health, Repatriation General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Adelaide Institute for Sleep Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anand R Rose, MD, FRACP (61882769666 ext. 247, anand.rose@health.sa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sleep disordered breathing in patients on long term opiates. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2008.