Transient Ischemic AttackSleepTightNCT01446913

Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure

A study testing Standard CPAP Intervention and Enhanced CPAP Intervention in people with Transient Ischemic Attack and Stroke, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Transient Ischemic Attack, Stroke
What is being tested?: Standard CPAP Intervention and Enhanced CPAP Intervention
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 2 sitesUnited States
Study dates: May 2011to Apr 2014
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years and older
TIA or ischemic stroke
within 1 week of neurological symptom onset
brain imaging within 24 hours

Who cannot join

known to have sleep apnea
suspected sleep disorder other than sleep apnea
hospice patients or patients receiving comfort only measures
patients unable to use a nasal or face mask
patients who require mechanical ventilation
Non English language patients

Show all 10Show fewer

inability to provide informed consent
active suicidal ideation
live outside the recruitment area
provider does not allow researcher to contact patient

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Indiana
Indianapolis, Indiana, 46202
Yale University
New Haven, Connecticut, 06511

Other trials in United States

About this study

The goal of this study is to develop a novel study design to safely and ethically conduct a long-term randomized controlled trial among patients at high risk for both sleep apnea and cardiovascular events that will examine whether effective positive airway pressure(PAP) therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular death)in the first year post event, despite current prevent strategies. Therefore, the treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular outcomes in this high risk population.

Read the detailed description

The proposed study is a randomized controlled trial among patients with transient ischemic attack (TIA) and minor stroke, comparing strategies for the diagnosis and treatment of sleep apnea with usual care over 6-12 months at 2 sites (Yale University School of Medicine and Indiana University School of Medicine). Patients with TIA and minor stroke will be randomly assigned to either usual care or a diagnosis and treatment approach that includes ambulatory polysomnography and initiation of autotitrating CPAP for sleep apnea in a 1:2 (control:intervention) randomization scheme. Intervention patients with sleep apnea will receive either a standard CPAP treatment intervention or an enhanced protocol designed to increase long-term CPAP adherence. The primary outcomes will include: (a) the impact of CPAP on pathophysiologic markers in the following domains of cardiovascular risk: inflammation (CRP, Il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma catecholamines and heart rate variability (HRV)), insulin resistance (HOMA-IR, HbA1C), endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media thickness); and (b) long-term (6-12 month) CPAP adherence.

Conditions: Transient Ischemic Attack, Stroke
Being tested: Standard CPAP Intervention, Enhanced CPAP Intervention
Keywords: Sleep Apnea, CPAP adherence, behavioral adherence, stroke
Medical subject headings: Ischemic Attack, Transient, Stroke, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard CPAP InterventionDevice
Enhanced CPAP InterventionBehavioural

Study groups in NCT01446913
Study group	Role	What they receive
Standard Intervention group	Active comparator	This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support. Receives: Device: Standard CPAP Intervention
Enhanced CPAP intervention	Active comparator	This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support. Receives: Behavioral: Enhanced CPAP Intervention
Usual Care	No intervention	This group usual care after TIA/stroke and a sleep study at the end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

HOMA IR Change From Baseline
The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.). The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline and up to 12 months
CRP Change From Baseline
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline and up to 12 months
IL-6 Change From Baseline
IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. Il-6 is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline and up to 12 months
Catecholamine Change From Baseline
Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamine is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline and up to 12 months
Heart Rate Variability Change From Baseline
Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline and up to 12 months
24-H Systolic Blood Pressure Mean Change From Baseline
24-H Systolic Blood Pressure is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline and up to 12 months
Flow-mediated Vasodilation Mean Change From Baseline
Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
Carotid Intima-Medial Thickness Mean Change From Baseline
Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness mean change is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
CPAP Adherence Rates Change From Baseline
CPAP adherence rates were calculated as hours of CPAP use per night. The change from baseline up until the final measurement (up to 12 months) was assessed. The Respironics M-series (now System One, Phillips Respironics, North Ryde, Australia) produced a record of the patient adherence (hours of use per night) throughout the duration of the follow up period.
Measured: Baseline to up to 12 months

Secondary outcomes (9)

HOMA IR Change From Baseline With CPAP Use
The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.) To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
CRP Change From Baseline With CPAP Use
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
IL-6 Change From Baseline With CPAP Use
IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. IL-6 is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
Catecholamine Change From Baseline With CPAP Use
Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamines change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
Heart Rate Variability Change From Baseline With CPAP Use
Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use
24-H Mean Systolic Blood Pressure change is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use
Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months
Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change
Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. The carotid intimal thickness measurement was obtained by averaging the distance between the lumen-intima interface and the media-adventitia interface obtained from 5 contiguous sites 1 mm apart.
Measured: Baseline to up to 12 months
Medication-adjusted 24-H SBP Change From Baseline
Change in medication-adjusted 24-hour SBP, which is calculated as [mean 24-hour SBP in mmHg] + [patient's DDD × (8.0 mmHg), was assessed between CPAP adherence groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Measured: Baseline to up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Apr 2014

First posted5 Oct 2011 (estimated)
Study startMay 2011
Primary completionDec 2013
Study completionApr 2014

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 (2)Papers the sponsor has linked to this study.
Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
More trials run by Yale 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01446913
Sponsor's protocol ID: 1101007811
Other IDs: U34HL105285-01
Acronym: SleepTight
Status last verified: Oct 2020
First submitted: 3 Oct 2011
Last updated: 18 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Resource sharing plan In compliance NIH recommendations, we affirm our commitment to share our final research data in a timely fashion for this proposed study with the scientific community. We intend this to occur no later than the time of acceptance for publication of the main findings from the final dataset. We will share all data from the funded research that can be shared without compromising individual subjects' rights and privacy, regardless of whether the data have been used for publication.

Publications

Koo BB, Bravata DM, Tobias LA, Mackey JS, Miech EJ, Matthias MS, Stahl SM, Sico JJ, Vaz Fragoso CA, Williams LS, Lampert R, Qin L, Yaggi HK. Observational Study of Obstructive Sleep Apnea in Wake-Up Stroke: The SLEEP TIGHT Study. Cerebrovasc Dis. 2016;41(5-6):233-41. doi: 10.1159/000440736. Epub 2016 Jan 27.
PubMed 26811929
Yaggi HK, Mittleman MA, Bravata DM, Concato J, Ware J, Stoney CM, Redline S. Reducing cardiovascular risk through treatment of obstructive sleep apnea: 2 methodological approaches. Am Heart J. 2016 Feb;172:135-43. doi: 10.1016/j.ahj.2015.07.033. Epub 2015 Sep 11.
PubMed 26856225

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
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Recruiting
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All Transient Ischemic Attack trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure
ClinicalTrials.gov ID: NCT01446913
Acronym / sponsor ID: SleepTight / 1101007811
Conditions: Transient Ischemic Attack, Stroke
Keywords: Sleep Apnea, CPAP adherence, behavioral adherence, stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 255 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Indiana University
Study start: May 2011
Primary completion: Dec 2013 (actual)
Study completion: Apr 2014 (actual)
First posted: 5 Oct 2011 (estimated)
Results: Posted 18 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Standard Intervention group	Active comparator	Device: Standard CPAP InterventionThis group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.
Enhanced CPAP intervention	Active comparator	Behavioral: Enhanced CPAP InterventionThis group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.
Usual Care	No intervention	–This group usual care after TIA/stroke and a sleep study at the end of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years and older
TIA or ischemic stroke
within 1 week of neurological symptom onset
brain imaging within 24 hours

Key exclusion criteria (10 listed)

known to have sleep apnea
suspected sleep disorder other than sleep apnea
hospice patients or patients receiving comfort only measures
patients unable to use a nasal or face mask
patients who require mechanical ventilation

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
Standard CPAP Intervention	Device	Standard Intervention group
Enhanced CPAP Intervention	Behavioural	Enhanced CPAP intervention

Primary outcome

HOMA IR Change From Baseline
Time frame: Baseline and up to 12 months
The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.). The change from baseline up until the final measurement (up to 12 months) was assessed.
CRP Change From Baseline
Time frame: Baseline and up to 12 months
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
IL-6 Change From Baseline
Time frame: Baseline and up to 12 months
IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. Il-6 is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Catecholamine Change From Baseline
Time frame: Baseline and up to 12 months
Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamine is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Heart Rate Variability Change From Baseline
Time frame: Baseline and up to 12 months
Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
24-H Systolic Blood Pressure Mean Change From Baseline
Time frame: Baseline and up to 12 months
24-H Systolic Blood Pressure is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. The change from baseline up until the final measurement (up to 12 months) was assessed.
Flow-mediated Vasodilation Mean Change From Baseline
Time frame: Baseline to up to 12 months
Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. The change from baseline up until the final measurement (up to 12 months) was assessed.
Carotid Intima-Medial Thickness Mean Change From Baseline
Time frame: Baseline to up to 12 months
Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness mean change is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
CPAP Adherence Rates Change From Baseline
Time frame: Baseline to up to 12 months
CPAP adherence rates were calculated as hours of CPAP use per night. The change from baseline up until the final measurement (up to 12 months) was assessed. The Respironics M-series (now System One, Phillips Respironics, North Ryde, Australia) produced a record of the patient adherence (hours of use per night) throughout the duration of the follow up period.

9 secondary outcomes

HOMA IR Change From Baseline With CPAP Use
Time frame: Baseline to up to 12 months
CRP Change From Baseline With CPAP Use
Time frame: Baseline to up to 12 months
IL-6 Change From Baseline With CPAP Use
Time frame: Baseline to up to 12 months
Catecholamine Change From Baseline With CPAP Use
Time frame: Baseline to up to 12 months
Heart Rate Variability Change From Baseline With CPAP Use
Time frame: Baseline to up to 12 months
24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use
Time frame: Baseline to up to 12 months
Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use
Time frame: Baseline to up to 12 months
Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change
Time frame: Baseline to up to 12 months
Medication-adjusted 24-H SBP Change From Baseline
Time frame: Baseline to up to 12 months

Results and safety

Results posted to the registry on 18 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Intervention Group	86	77
Enhanced CPAP Intervention	82	73
Usual Care	84	73

Primary outcome: HOMA IR Change From Baseline

Time frame: Baseline and up to 12 months. Mean (Standard Deviation). Unit: HOMA-IR Index

Measure	Standard Intervention Group n = 86	Enhanced CPAP Intervention n = 82	Usual Care n = 84
Value	0.9 (3.0)	4.0 (12.7)	4.1 (24.8)

Population analysed: Intention to treat analysis population.

Primary outcome: CRP Change From Baseline

Time frame: Baseline and up to 12 months. Mean (Standard Deviation). Unit: mg/dl

Measure	Standard Intervention Group n = 86	Enhanced CPAP Intervention n = 82	Usual Care n = 84
Value	0.8 (14.4)	0.9 (10.2)	-3.0 (13.0)

Population analysed: Intention to treat analysis.

Primary outcome: IL-6 Change From Baseline

Time frame: Baseline and up to 12 months. Mean (Standard Deviation). Unit: pg/ml

Measure	Standard Intervention Group n = 86	Enhanced CPAP Intervention n = 82	Usual Care n = 84
Value	4.0 (11)	1.8 (40.6)	-0.7 (3.9)

Population analysed: Intention to treat analysis.

Primary outcome: Catecholamine Change From Baseline

Time frame: Baseline and up to 12 months. Mean (Standard Deviation). Unit: pg/ml

Measure	Standard Intervention Group n = 86	Enhanced CPAP Intervention n = 82	Usual Care n = 84
Value	192.4 (385.0)	5.8 (259.6)	89.0 (231.8)

Population analysed: Intention to treat analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored through the 12 month follow up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Intervention Group	3 of 86 (3.5%)	2 of 86 (2.3%)	0 of 86
Enhanced CPAP Intervention	6 of 82 (7.3%)	3 of 82 (3.7%)	4 of 82
Usual Care	7 of 84 (8.3%)	3 of 84 (3.6%)	2 of 84

Limitations and caveats (from the sponsor): A study design which compares the effectiveness of a diagnostic and treatment strategy to usual care may result in an underestimate of the efficacy and potency of CPAP on our outcomes. Not all patients in the intervention strategy had sleep apnea.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26811929Koo BB, Bravata DM, Tobias LA, Mackey JS, Miech EJ, Matthias MS, Stahl SM, Sico JJ, Vaz Fragoso CA, Williams LS, Lampert R, Qin L, Yaggi HK. Observational Study of Obstructive Sleep Apnea in Wake-Up Stroke: The SLEEP TIGHT Study. Cerebrovasc Dis. 2016;41(5-6):233-41. doi: 10.1159/000440736. Epub 2016 Jan 27.
Derived from this study: PubMed 26856225Yaggi HK, Mittleman MA, Bravata DM, Concato J, Ware J, Stoney CM, Redline S. Reducing cardiovascular risk through treatment of obstructive sleep apnea: 2 methodological approaches. Am Heart J. 2016 Feb;172:135-43. doi: 10.1016/j.ahj.2015.07.033. Epub 2015 Sep 11.
Individual participant dataSharing planned: Yes. Resource sharing plan In compliance NIH recommendations, we affirm our commitment to share our final research data in a timely fashion for this proposed study with the scientific community. We intend this to occur no later than the time of acceptance for publication of the main findings from the final dataset. We will share all data from the funded research that can be shared without compromising individual subjects' rights and privacy, regardless of whether the data have been used for publication.

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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.

Henry Yaggi, MD,MPH principal investigator

Yale University

Dawn M Bravata, M.D. principal investigator

Indiana University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard CPAP Intervention and Enhanced CPAP Intervention in people with Transient Ischemic Attack and Stroke, run by Yale University at 2 sites 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 4 inclusion and 10 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 18 Nov 2020. 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 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 18 Nov 2020). 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?

HOMA IR Change From Baseline (time frame: Baseline and up to 12 months). The study lists 9 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 NCT01446913, which also lists 2 linked publications.

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 18 Nov 2020.