Obstructive Sleep ApneaNCT00681161
Autonomic Function in Obstructive Sleep Apnea
A study testing continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- continuous positive airway pressure (CPAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2012
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80.
- BMI between 25 and 35.
- Symptoms strongly indicative of sleep apnea (loud snoring, witnessed apneas or history of OSA based on laboratory PSG within 3 months of screening, not currently using CPAP, oral appliances or other treatments for OSA)
Who cannot join
- History of previous treatment for OSA.
- History of diabetes.
- History of other disorders known to affect autonomic function (e.g. Parkinson's disease, peripheral neuropathy of any cause, or requiring medications known to affect autonomic function that cannot be stopped safely for 48 hours).
- No evidence of peripheral neuropathy on examination, negative laboratory tests for common causes of neuropathy (B12, Thyroid stimulating hormone, serum protein electrophoresis).
- Inability to cooperate with testing, or to undergo testing (individuals with irregular heart rhythms, significant lung disease, previous LASIK procedure, unable to stop hypertensive medications for 48 hours).
- Medications affecting glucose levels, hypoglycemic agents, high dose thiazide diuretics, beta blocking agents.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Function in Obstructive Sleep Apnea (OSA)
The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia.
Read the detailed description
The purpose of this study is to determine if obstructive sleep apnea (OSA)-a condition in which respiration and oxygenation are affected during sleep-can cause abnormal autonomic function and blood sugar (glucose) processing, which could lead to diabetes, or pre-diabetic conditions. The autonomic system controls heart rate, blood pressure, breathing, and other functions of the body. OSA and diabetes are commonly found in overweight individuals and both can cause increased risk of heart disease and strokes. OSA can be treated using nasal continuous positive airway pressure (CPAP) which overcomes the obstruction to airflow that occurs in OSA.
In this study, the scientists hope to determine if individuals with OSA have an increased prevalence of undiagnosed diabetes or pre-diabetic conditions, and if autonomic abnormalities observed previously in OSA are more severe or more common in people with OSA and diabetes or pre-diabetic conditions.
Participants will undergo a sleep study and glucose studies to determine if they have sleep apnea and impaired fasting glucose, impaired glucose tolerance, or undiagnosed diabetes (collectively called impaired glucose regulation).
Individuals with sleep apnea with and without glucose abnormalities will be age and BMI matched, and will undergo further autonomic and peripheral nerve testing. Individuals without diabetes will be followed for one year of CPAP treatment for their sleep apnea-with visits at 3 month intervals to evaluate glucose and autonomic function. Individuals without sleep apnea or diabetes will also undergo autonomic and peripheral nerve testing. Participants will also complete questionnaires to assess their sleepiness and symptoms of autonomic function.
Results from this study will help researchers determine if abnormalities of autonomic function seen in people with OSA are caused by OSA or by coexistent impaired glucose regulation present in people with OSA. In addition, results from the study will show if CPAP treatment improves autonomic dysfunction by correcting breathing abnormalities, or by secondary improvement of glucose regulation.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- continuous positive airway pressure (CPAP)
- Keywords
- obstructive sleep apnea, OSA, diabetes, pre-diabetic condition, obesity, blood glucose, continuous positive airway pressure, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure (CPAP)Other
Standard of care treatment for OSA, requires a mask attached by tubing to a device providing continuous pressure of air at a given cm of water pressure, acting as a splint to open airway at night to relieve obstruction.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Other: continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose level, composite autonomic system score (CASS), homeostasis assessment model (HOMA), insulin sensitivity index (ISI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMar 2006
- Primary completionMar 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Peltier, Vanderbilt University
- Investigators
- Amanda C. Peltier, MD, MS, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681161
- Sponsor's protocol ID
- K23NS056009
- Other IDs
- 1K23NS056009-01A1
- Status last verified
- Feb 2017
- First submitted
- 19 May 2008
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Peltier AC, Bagai K, Artibee K, Diedrich A, Garland E, Elasy T, Shi Y, Wang L, Feldman EL, Robertson D, Malow BA. Effect of mild hyperglycemia on autonomic function in obstructive sleep apnea. Clin Auton Res. 2012 Feb;22(1):1-8. doi: 10.1007/s10286-011-0131-9. Epub 2011 Jul 28.
PubMed 21796355
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Function in Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT00681161
- Acronym / sponsor ID
- K23NS056009
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, OSA, diabetes, pre-diabetic condition, obesity, blood glucose, continuous positive airway pressure, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2006 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 May 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.
The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia.
Detailed description
The purpose of this study is to determine if obstructive sleep apnea (OSA)-a condition in which respiration and oxygenation are affected during sleep-can cause abnormal autonomic function and blood sugar (glucose) processing, which could lead to diabetes, or pre-diabetic conditions. The autonomic system controls heart rate, blood pressure, breathing, and other functions of the body. OSA and diabetes are commonly found in overweight individuals and both can cause increased risk of heart disease and strokes. OSA can be treated using nasal continuous positive airway pressure (CPAP) which overcomes the obstruction to airflow that occurs in OSA.
In this study, the scientists hope to determine if individuals with OSA have an increased prevalence of undiagnosed diabetes or pre-diabetic conditions, and if autonomic abnormalities observed previously in OSA are more severe or more common in people with OSA and diabetes or pre-diabetic conditions.
Participants will undergo a sleep study and glucose studies to determine if they have sleep apnea and impaired fasting glucose, impaired glucose tolerance, or undiagnosed diabetes (collectively called impaired glucose regulation).
Individuals with sleep apnea with and without glucose abnormalities will be age and BMI matched, and will undergo further autonomic and peripheral nerve testing. Individuals without diabetes will be followed for one year of CPAP treatment for their sleep apnea-with visits at 3 month intervals to evaluate glucose and autonomic function. Individuals without sleep apnea or diabetes will also undergo autonomic and peripheral nerve testing. Participants will also complete questionnaires to assess their sleepiness and symptoms of autonomic function.
Results from this study will help researchers determine if abnormalities of autonomic function seen in people with OSA are caused by OSA or by coexistent impaired glucose regulation present in people with OSA. In addition, results from the study will show if CPAP treatment improves autonomic dysfunction by correcting breathing abnormalities, or by secondary improvement of glucose regulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: continuous positive airway pressure (CPAP) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21-80.
- BMI between 25 and 35.
- Symptoms strongly indicative of sleep apnea (loud snoring, witnessed apneas or history of OSA based on laboratory PSG within 3 months of screening, not currently using CPAP, oral appliances or other treatments for OSA)
Key exclusion criteria (7 listed)
- History of previous treatment for OSA.
- History of diabetes.
- History of other disorders known to affect autonomic function (e.g. Parkinson's disease, peripheral neuropathy of any cause, or requiring medications known to affect autonomic function that cannot be stopped safely for 48 hours).
- No evidence of peripheral neuropathy on examination, negative laboratory tests for common causes of neuropathy (B12, Thyroid stimulating hormone, serum protein electrophoresis).
- Inability to cooperate with testing, or to undergo testing (individuals with irregular heart rhythms, significant lung disease, previous LASIK procedure, unable to stop hypertensive medications for 48 hours).
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 |
|---|---|---|
| continuous positive airway pressure (CPAP)Standard of care treatment for OSA, requires a mask attached by tubing to a device providing continuous pressure of air at a given cm of water pressure, acting as a splint to open airway at night to relieve obstruction. | Other | A |
Primary outcome
blood glucose level, composite autonomic system score (CASS), homeostasis assessment model (HOMA), insulin sensitivity index (ISI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Results publication: PubMed 21796355Peltier AC, Bagai K, Artibee K, Diedrich A, Garland E, Elasy T, Shi Y, Wang L, Feldman EL, Robertson D, Malow BA. Effect of mild hyperglycemia on autonomic function in obstructive sleep apnea. Clin Auton Res. 2012 Feb;22(1):1-8. doi: 10.1007/s10286-011-0131-9. Epub 2011 Jul 28.
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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.
Amanda C. Peltier, MD, MS principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea, run by Vanderbilt 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?
The sponsor lists 3 inclusion and 7 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: finished, as of the sponsor's last update on 24 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blood glucose level, composite autonomic system score (CASS), homeostasis assessment model (HOMA), insulin sensitivity index (ISI) (time frame: 6 months). 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 NCT00681161, 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 24 Feb 2017.