Sleep Apnea, ObstructiveNCT00672737
Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Stanford University at 1 site in United States.
Trial summary
We would like to test the effect of opioid medication on pain sensitivity in subjects who have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to other subjects without OSA. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Remifentanil, Cold pain threshold and tolerance and Heat pain threshold and tolerance
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Males at risk for obstructive sleep apnea (OSA). We invited male volunteers (18 55 years old) with a history of habitual snoring and/or a formal diagnosis of OSA to participate in a study evaluating sleep and experimental pain processing.
Inclusion Criteria:1. Male 2 .18 - 55 years of age 3. Body mass index (BMI) lower or equal to 30 kg/m2 4. Absence of severe systemic disease that results in functional limitations (i.e. poorly controlled hypertension, angina pectoris, prior myocardial infarction, pulmonary disease that limits activity) 5.Subjects must be able to comprehend spoken and written English
Exclusion Criteria:1. Major psychiatric, neurological, or neuromuscular disorder 2. Known diabetes mellitus or thyroid disease 3. Allergy to study medication (remifentanil) 4. History of addiction 5. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. 6. Chronic or acute use of opioids, or other medications affecting the CNS.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Experimental Pain Processing and Autonomic Function in Subjects Suffering From Obstructive Sleep Apnea
We would like to test the effect of opioid medication on pain sensitivity in subjects who have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to other subjects without OSA. Patients with OSA may have an altered sensitivity to the sedative, analgesic, and respiratory depressant effects of opioids.
Read the detailed description
The purpose of the study is to test the hypothesis that patients who suffer from moderate-to-severe OSA have increased pain thresholds and are more sensitive to the analgesic effects of opioids compared to patients with normal sleep-related breathing physiology. We will evaluate the effect of remifentanil, a short acting mu-opioid receptor agonist, on pain using an experimental heat and cold-induced pain tests, and compare it between volunteers with and without a polysomnography (PSG)-based diagnosis of obstructive sleep apnea.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Remifentanil, Cold pain threshold and tolerance, Heat pain threshold and tolerance, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order.
Cold pain threshold and toleranceProcedure or surgery
Ice water was used to assess cold-related pain threshold and tolerance, defined as the time that the volunteers could keep their hands in the water before they started feeling pain or this feeling becomes unbearable, for threshold and tolerance, respectively.
Heat pain threshold and toleranceDevice
TSAII Neuroanalyzer (Medoc Advanced Medical Systems, Durham, NC), was used to assess the heat-related pain and tolerance of the volunteers defined as the respective temperatures where they started feeling as painful or unbearable.
PolysomnographyProcedure or surgery
Also called sleep study
All volunteers underwent a polysomnography study at home or at Stanford Sleep Center, approximately one week before their experimental pain assessment in the laboratory
| Study group | Role | What they receive |
|---|---|---|
| Males at risk for OSA | Males at risk for obstructive sleep apnea were invited to have a "sleep study" either at home or at Stanford Sleep Center.
A week after their sleep study (Polysomnography), all volunteers underwent quantitative sensory testing in the laboratory, during which their pain thresholds and tolerances to heat (Heat pain threshold and tolerance) and cold (Cold pain threshold and tolerance) stimuli were assessed, under two different concentrations (1 and 2 mcg/mL, in randomized order) of remifentanil, a short-acting opioid, given as a computer-controlled infusion. Receives: Drug: Remifentanil; Procedure: Cold pain threshold and tolerance; Device: Heat pain threshold and tolerance; Procedure: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experimental Cold-induced Pain - IGFBP-1
The effect of insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated beta (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in the serum level of IGFBP-1, cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.
Measured: 2 to 3 weeks
Experimental Heat-induced Pain - IGFBP-1
The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in serum level of IGFBP-1, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.
Measured: 2 to 3 weeks
Experimental Cold-induced Pain - SaO2
The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography) on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.
Measured: 2 to 3 weeks
Experimental Heat-induced Pain - SaO2
The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography), on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.
Measured: 2 to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Doufas, Stanford University
- Investigators
- Anthony Doufas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672737
- Sponsor's protocol ID
- SU-01222008-985
- Other IDs
- 10374
- Status last verified
- Jan 2017
- First submitted
- 2 May 2008
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Doufas AG, Tian L, Padrez KA, Suwanprathes P, Cardell JA, Maecker HT, Panousis P. Experimental pain and opioid analgesia in volunteers at high risk for obstructive sleep apnea. PLoS One. 2013;8(1):e54807. doi: 10.1371/journal.pone.0054807. Epub 2013 Jan 29.
PubMed 23382975
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Pain Processing and Autonomic Function in Subjects Suffering From Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00672737
- Acronym / sponsor ID
- SU-01222008-985
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We would like to test the effect of opioid medication on pain sensitivity in subjects who have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to other subjects without OSA. Patients with OSA may have an altered sensitivity to the sedative, analgesic, and respiratory depressant effects of opioids.
Detailed description
The purpose of the study is to test the hypothesis that patients who suffer from moderate-to-severe OSA have increased pain thresholds and are more sensitive to the analgesic effects of opioids compared to patients with normal sleep-related breathing physiology. We will evaluate the effect of remifentanil, a short acting mu-opioid receptor agonist, on pain using an experimental heat and cold-induced pain tests, and compare it between volunteers with and without a polysomnography (PSG)-based diagnosis of obstructive sleep apnea.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males at risk for OSA | – | Drug: Remifentanil, Procedure: Cold pain threshold and tolerance, Device: Heat pain threshold and tolerance, Procedure: PolysomnographyMales at risk for obstructive sleep apnea were invited to have a "sleep study" either at home or at Stanford Sleep Center. A week after their sleep study (Polysomnography), all volunteers underwent quantitative sensory testing in the laboratory, during which their pain thresholds and tolerances to heat (Heat pain threshold and tolerance) and cold (Cold pain threshold and tolerance) stimuli were assessed, under two different concentrations (1 and 2 mcg/mL, in randomized order) of remifentanil, a short-acting opioid, given as a computer-controlled infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males at risk for obstructive sleep apnea (OSA). We invited male volunteers (18 55 years old) with a history of habitual snoring and/or a formal diagnosis of OSA to participate in a study evaluating sleep and experimental pain processing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilRemifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order. | Drug | Males at risk for OSA |
| Cold pain threshold and toleranceIce water was used to assess cold-related pain threshold and tolerance, defined as the time that the volunteers could keep their hands in the water before they started feeling pain or this feeling becomes unbearable, for threshold and tolerance, respectively. | Procedure or surgery | Males at risk for OSA |
| Heat pain threshold and toleranceTSAII Neuroanalyzer (Medoc Advanced Medical Systems, Durham, NC), was used to assess the heat-related pain and tolerance of the volunteers defined as the respective temperatures where they started feeling as painful or unbearable. | Device | Males at risk for OSA |
| PolysomnographyAlso: sleep studyAll volunteers underwent a polysomnography study at home or at Stanford Sleep Center, approximately one week before their experimental pain assessment in the laboratory | Procedure or surgery | Males at risk for OSA |
Primary outcome
Experimental Cold-induced Pain - IGFBP-1
Time frame: 2 to 3 weeks
The effect of insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated beta (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in the serum level of IGFBP-1, cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.
Experimental Heat-induced Pain - IGFBP-1
Time frame: 2 to 3 weeks
The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in serum level of IGFBP-1, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.
Experimental Cold-induced Pain - SaO2
Time frame: 2 to 3 weeks
The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography) on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.
Experimental Heat-induced Pain - SaO2
Time frame: 2 to 3 weeks
The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography), on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23382975Doufas AG, Tian L, Padrez KA, Suwanprathes P, Cardell JA, Maecker HT, Panousis P. Experimental pain and opioid analgesia in volunteers at high risk for obstructive sleep apnea. PLoS One. 2013;8(1):e54807. doi: 10.1371/journal.pone.0054807. Epub 2013 Jan 29.
- Individual participant dataSharing planned: No
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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.
Anthony Doufas principal investigator
Stanford University
1 site 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, Obstructive, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experimental Cold-induced Pain - IGFBP-1 (time frame: 2 to 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672737, which also lists 1 linked publication.
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 7 Aug 2017.