Sleep Apnea, ObstructivePhase 3OSA_DMNCT00801892
Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
A Phase 3 study testing Continuous Positive Airway Pressure (CPAP) in people with Sleep Apnea, Obstructive and Diabetes Mellitus, Type 2, run by Eileen R. Chasens at 1 site in United States.
Trial summary
Daily physical activity is important to achieve glucose control in persons with type 2 diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime symptom, excessive sleepiness, act as barriers to physical activity. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- Phase
- Phase 3
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2DM (verified by primary care provider (PCP) or medication for T2DM)
- AHI (from PSG) greater than > 15
- A1c < 9.0%
- Epworth Sleepiness Sca;e > 10 (Baseline Assessment)
- Able to ambulate independently or with a cane
- Age 40-65 years
Show all 13Show fewer
- BMI< 45
- No acute medical and psychiatric illness in past 3 months
- Self-reported sleep duration of at least 6 hours
- No changes in medications, including diabetic medications, in last 3 months
- Telephone access
- Able to perform study tests (e.g., speak, read and write in English)
- Willing to be randomized to CPAP or sham-CPAP
Who cannot join
- Diagnosis of another sleep disorder, in addition to OSA,
- Oxygen or Bi-level positive airway pressure required for treatment of OSA
- An oxygen saturation <75% for >10% of the diagnostic PSG or if subject has oxygen saturation <75% for >25% of the first 4 h of the diagnostic PSG
- Any individual in the household currently or with history of CPAP treatment
- Type 1 or gestational diabetes
- Prescribed insulin for treatment of type 2 diabetes
Show all 16Show fewer
- Regular use (> 3 times/week) of hypnotic or alerting medications
- History of a near-miss or automobile accident due to sleepiness
- Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer
- Currently working night or rotating shifts
- Routine consumption of alcohol as determined by >2 drinks day
- Known allergy to medical adhesives or dermatological conditions that would preclude wearing CGMS
- Swim or water aerobics >once a week
- Participation in contact sports or activity that may damage CGMS device or cause injury from monitor
- Claustrophobia that prevents wearing the CPAP mask
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: OSA, Sleepiness, and Activity in Diabetes Management
Daily physical activity is important to achieve glucose control in persons with type 2 diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime symptom, excessive sleepiness, act as barriers to physical activity. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure results in increased physical activity in persons with type 2 diabetes.
Read the detailed description
Obstructive sleep apnea (OSA) is a serious disorder characterized by episodic obstruction of the pharyngeal airway accompanied by cessation or reduction in airflow. Untreated OSA has a negative impact 24 hours a day, disrupting nighttime sleep and causing excessive daytime sleepiness that interferes with functioning. Recent studies suggest that OSA and type 2 diabetes (T2DM) not only co-exist but that OSA may adversely affect glucose homeostasis. While physical activity is recognized as beneficial to persons with T2DM, OSA severity or daytime sleepiness may act to hinder persons with T2DM from participating in physical activity. The primary aim of this pilot/feasibility study is to obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a double blind, randomized, placebo-controlled study to examine physical activity in subjects with T2DM and OSA who are treated with CPAP compared to subjects on sham-CPAP. The secondary aims are to explore: 1) the interrelationships of OSA severity, daytime sleepiness, and physical activity on glucose variability at baseline; 2) average pre-post therapy changes in glucose variability in subjects treated with CPAP compared to subjects receiving sham-CPAP, and 3) pre to post therapy changes in weight, diet, residual sleepiness and mood in subjects treated with CPAP compared to subjects receiving sham-CPAP.
The primary endpoint of the study, physical activity, will be measured by the Bodymedia SenseWear Pro Armband® to determine activity counts. The endpoint for glucose variability will be measured by the Medtronic Continuous Glucose Monitoring System (CGMS). Adherence to CPAP will be measured by a Smart Card® inserted in subjects' CPAP machines. We will limit the sample of subjects who are randomized to CPAP or sham-CPAP to persons with an adequate sleep duration pre-treatment (> 6 hours), with moderate or severe OSA and with EDS to have a more homogenous, profoundly affected sample for this pilot study. The information that will result from the proposed study on of the effect of OSA and EDS on glucose variability has the potential to lead to the development of improved behavioral interventions in persons with diabetes. In addition, this study contains measures of diet and mood to begin to elucidate the possible effects of OSA and EDS on diabetes management.
- Being tested
- Continuous Positive Airway Pressure (CPAP), Sham- Continuous Positive Airway Pressure (Sham-CPAP)
- Keywords
- daytime sleepiness, obstructive sleep apnea, type 2 diabetes mellitus, diabetes management
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
Sham- Continuous Positive Airway Pressure (Sham-CPAP)Device
Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
| Study group | Role | What they receive |
|---|---|---|
| 1 subjects treated with CPAP | Active comparator | Continuous Positive Airway Pressure treatment (CPAP) Receives: Device: Continuous Positive Airway Pressure (CPAP) |
| 2 subjects treated with sham-CPAP | Sham comparator | Sham Continuous Positive Airway Pressure treatment (sham-CPAP) Receives: Device: Sham- Continuous Positive Airway Pressure (Sham-CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity, Steps Walked
Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
Measured: after one-month treatment
Secondary outcomes (5)
Fructosamine
Change in fructosamine level from baseline to one month: data from main study period
Measured: after one-month
Change in Sleep Quality
From Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period
Measured: after one month
Change in Daytime Sleepiness During Main Study Period
Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness
Measured: after one month
Change in Vigor-Activity During Main Study Period
Vigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity
Measured: after one month
Fatigue/Inertia
Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia
Measured: after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionApr 2012
- Study completionApr 2012
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.
- Other trials for Sleep Apnea, ObstructiveStudies 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants on sham-CPAP were allowed to try actual CPAP.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eileen R. Chasens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eileen R. Chasens, University of Pittsburgh
- Investigators
- Eileen R. Chasens, DSN, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801892
- Sponsor's protocol ID
- R21HL089522-01A2
- Acronym
- OSA_DM
- Status last verified
- Nov 2017
- First submitted
- 3 Dec 2008
- Last updated
- 8 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSA, Sleepiness, and Activity in Diabetes Management
- ClinicalTrials.gov ID
- NCT00801892
- Acronym / sponsor ID
- OSA_DM / R21HL089522-01A2
- Keywords
- daytime sleepiness, obstructive sleep apnea, type 2 diabetes mellitus, diabetes management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Eileen R. ChasensUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Posted 27 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Daily physical activity is important to achieve glucose control in persons with type 2 diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime symptom, excessive sleepiness, act as barriers to physical activity. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure results in increased physical activity in persons with type 2 diabetes.
Detailed description
Obstructive sleep apnea (OSA) is a serious disorder characterized by episodic obstruction of the pharyngeal airway accompanied by cessation or reduction in airflow. Untreated OSA has a negative impact 24 hours a day, disrupting nighttime sleep and causing excessive daytime sleepiness that interferes with functioning. Recent studies suggest that OSA and type 2 diabetes (T2DM) not only co-exist but that OSA may adversely affect glucose homeostasis. While physical activity is recognized as beneficial to persons with T2DM, OSA severity or daytime sleepiness may act to hinder persons with T2DM from participating in physical activity. The primary aim of this pilot/feasibility study is to obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a double blind, randomized, placebo-controlled study to examine physical activity in subjects with T2DM and OSA who are treated with CPAP compared to subjects on sham-CPAP. The secondary aims are to explore: 1) the interrelationships of OSA severity, daytime sleepiness, and physical activity on glucose variability at baseline; 2) average pre-post therapy changes in glucose variability in subjects treated with CPAP compared to subjects receiving sham-CPAP, and 3) pre to post therapy changes in weight, diet, residual sleepiness and mood in subjects treated with CPAP compared to subjects receiving sham-CPAP.
The primary endpoint of the study, physical activity, will be measured by the Bodymedia SenseWear Pro Armband® to determine activity counts. The endpoint for glucose variability will be measured by the Medtronic Continuous Glucose Monitoring System (CGMS). Adherence to CPAP will be measured by a Smart Card® inserted in subjects' CPAP machines. We will limit the sample of subjects who are randomized to CPAP or sham-CPAP to persons with an adequate sleep duration pre-treatment (> 6 hours), with moderate or severe OSA and with EDS to have a more homogenous, profoundly affected sample for this pilot study. The information that will result from the proposed study on of the effect of OSA and EDS on glucose variability has the potential to lead to the development of improved behavioral interventions in persons with diabetes. In addition, this study contains measures of diet and mood to begin to elucidate the possible effects of OSA and EDS on diabetes management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants on sham-CPAP were allowed to try actual CPAP.
| Arm | Type | Receives |
|---|---|---|
| 1 subjects treated with CPAP | Active comparator | Device: Continuous Positive Airway Pressure (CPAP)Continuous Positive Airway Pressure treatment (CPAP) |
| 2 subjects treated with sham-CPAP | Sham comparator | Device: Sham- Continuous Positive Airway Pressure (Sham-CPAP)Sham Continuous Positive Airway Pressure treatment (sham-CPAP) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- T2DM (verified by primary care provider (PCP) or medication for T2DM)
- AHI (from PSG) greater than > 15
- A1c < 9.0%
- Epworth Sleepiness Sca;e > 10 (Baseline Assessment)
- Able to ambulate independently or with a cane
Key exclusion criteria (16 listed)
- Diagnosis of another sleep disorder, in addition to OSA,
- Oxygen or Bi-level positive airway pressure required for treatment of OSA
- An oxygen saturation <75% for >10% of the diagnostic PSG or if subject has oxygen saturation <75% for >25% of the first 4 h of the diagnostic PSG
- Any individual in the household currently or with history of CPAP treatment
- Type 1 or gestational diabetes
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)Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas). | Device | 1 subjects treated with CPAP |
| Sham- Continuous Positive Airway Pressure (Sham-CPAP)Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas). | Device | 2 subjects treated with sham-CPAP |
Primary outcome
Physical Activity, Steps Walked
Time frame: after one-month treatment
Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
5 secondary outcomes
Fructosamine
Time frame: after one-month
Change in Sleep Quality
Time frame: after one month
Change in Daytime Sleepiness During Main Study Period
Time frame: after one month
Change in Vigor-Activity During Main Study Period
Time frame: after one month
Fatigue/Inertia
Time frame: after one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eileen R. Chasens, DSN principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous Positive Airway Pressure (CPAP) in people with Sleep Apnea, Obstructive and Diabetes Mellitus, Type 2, run by Eileen R. Chasens 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 13 inclusion and 16 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 8 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2014). 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?
Physical Activity, Steps Walked (time frame: after one-month treatment). 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 8 Nov 2017.