Obstructive Sleep ApneaNCT02703207
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
A study testing Positive airway pressure and NIPPV and /or oxygen in people with Obstructive Sleep Apnea and OSA COPD Overlap Syndrome, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Obstructive Sleep Apnea, OSA COPD Overlap Syndrome
- What is being tested?
- Positive airway pressure and NIPPV and /or oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2016to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15* per hour by polysomnography
- Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio <70% and FEV1 >30% and <80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking
- Age 60 years
- Male or female gender
Who cannot join
- Mild COPD
- Mild OSA
- Overlap Syndrome with mild OSA plus mild COPD
- Central sleep apnea defined as central apnea index >5 per hour
- Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
- Current smokers
Show all 22Show fewer
- Pregnant women
- Disorders of hypoventilation due to known neuromuscular or chest wall diseases**
- Patients with significant restrictive lung disease on pulmonary function testing
- Recent admission for any acute illness within the prior 4 months
- Current psychiatric illness requiring sedating medications
- Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
- For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score >10)
- History of learning disability
- Inability to sign consent
- Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
- Patients with unstable heart disease, decompensated heart failure, ejection fraction<45% or uncontrolled arrhythmias
- Patients unable to use either a nasal or face mask (e.g., facial trauma)
- Consumption of > 2 alcoholic beverages per day or past history of excessive alcohol use
- Current use of illicit drugs
- Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
- Life expectancy is less than 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
Lynn M Huber, 313-576-3106, lynn.huber@va.gov
Susmita Chowdhuri, MD MS
About this study
Official title: Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.
Read the detailed description
OBJECTIVE: Describe the clinical and physiological characteristics of obstructive sleep apnea (OSA) and comorbid chronic obstructive pulmonary disease (COPD) and study the impact of treatment on neurocognitive outcomes in elderly Veterans.
RESEARCH PLAN: The investigators will study if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness with reduced quality of life compared to patients with either OSA or COPD alone (Aim 3) and whether treatment with PAP/NIPPV and supplemental oxygen compared to CPAP alone in elderly Veterans with moderate-to-severe OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness and quality of life (QoL).
Aim A: To determine if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness compared to patients with either OSA or COPD.
Hypothesis: Elderly veterans (age 60 years) with moderate-to-severe OSA and concomitant moderate-to-severe COPD will have significantly increased cognitive deficits and daytime sleepiness compared with similar patients with OSA alone or COPD alone.
To study this aim the investigators will prospectively administer and compare the results of a battery of cognitive tests, and sleepiness and QoL questionnaires in elderly patients with OSA, COPD, and the Overlap Syndrome.
Aim B. To determine if treatment with PAP/NIPPV and/or supplemental oxygen compared to CPAP alone in elderly Veterans with OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness, and QoL.
Hypothesis: Therapy with PAP and supplemental oxygen will reverse neurocognitive deficits in one or more domains, reduce sleepiness, and improve QoL compared with CPAP alone in patients with moderate-to-severe OSA and concomitant moderate COPD. This aim will evaluate which specific deficits in neurocognitive function in patients with moderate-to-severe Overlap Syndrome are reversible and most sensitive to the effects of positive airway pressure (PAP) and oxygen vs CPAP alone.
To study this aim the investigators will randomize patients with the Overlap Syndrome to 3months of therapy with PAP and/or oxygen vs CPAP alone for 3 months and evaluate impact on neurocognitive function, sleepiness and quality of life before and after therapy.
- Conditions
- Obstructive Sleep Apnea, OSA COPD Overlap Syndrome
- Being tested
- Positive airway pressure, NIPPV and /or oxygen
- Keywords
- obstructive sleep apnea, COPD, Overlap syndrome, quality of life, neurocognitive function, sleepiness, elderly
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive airway pressureDevice
Also called Standard of care control arm
CPAP will be applied as standard of care for diagnosis of moderate to severe OSA
NIPPV and /or oxygenDevice
Also called Active intervention
supplemental oxygen will be applied to PAP/non-invasive positive pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| Positive airway pressure therapy | Active comparator | Control group patients will receive standard care with PAP- positive airway pressure. Receives: Device: Positive airway pressure; Device: NIPPV and /or oxygen |
| COPD | No intervention | The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria. |
| OSA and comorbid COPD | No intervention | Eligible elderly (age >/=60yrs) Veterans with moderate to severe Overlap Syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive function
The neurocognitive test - Trails A test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Measured: Change from baseline neurocognitive function at 3 months
Sleepiness
Epworth Sleepiness Scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome.
Measured: Change from baseline sleepiness at 3 months
Quality of life (Short-Form survey)
Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome.
Measured: Change from baseline quality of life at 3 months
Neurocognitive test
The neurocognitive test - Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Measured: Change from baseline at 3 months
Neurocognitive test (Paced Auditory Serial Addition Test)
The neurocognitive test: Paced Auditory Serial Addition Test (PASAT) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.
Measured: Change from baseline at 3 months
Neurocognitive test (Stroop Color-Word Interference)
The neurocognitive test: Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Measured: Change from baseline at 3 months
Neurocognitive test (DIGIT test)
The neurocognitive DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Measured: Change from baseline at 3 months
Neurocognitive test (Wechsler Abbreviated Scale of Intelligence)
The neurocognitive test: abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Measured: Change from baseline at 3 months
Quality of life (Functional Outcomes of Sleep Questionnaire)
Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ)-10. There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.
Measured: Change from baseline quality of life at 3 months
Quality of life (St. George's Respiratory Questionnaire)
Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.
Measured: Change from baseline quality of life at 3 months
Secondary outcomes (5)
Dyspnea
6 minute walk test (6MWT): Participants are instructed to achieve maximal distance. There is no scale, but a larger value is a better outcome.
Measured: Change from baseline at 3 months
Hours of nightly positive airway pressure (PAP) use/NIPPV use
Collection of PAP adherence data from the smart card of the PAP machine or from online data.
Measured: 90 days after start of therapy
Hours of nightly oxygen use
Adherence to supplemental oxygen (O2) will be determined by the total hours of nightly O2 use obtained from the O2 concentrator that is provided by the vendor.
Measured: 3 months after start of therapy
Borg scale
This measures the level of dyspnea during the 6 minute walk test. It is on a scale of 0-10, where a larger value is a worse outcome.
Measured: Change from baseline at 3 months
Blood pressure
Measure blood pressure at baseline visit
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start17 Aug 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susmita Chowdhuri, MD MS, Principal investigator, John D. Dingell VA Medical Center, Detroit, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703207
- Sponsor's protocol ID
- E2227-P
- Status last verified
- May 2026
- First submitted
- 18 Feb 2016
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
- ClinicalTrials.gov ID
- NCT02703207
- Acronym / sponsor ID
- E2227-P
- Conditions
- Obstructive Sleep Apnea, OSA COPD Overlap Syndrome
- Keywords
- obstructive sleep apnea, COPD, Overlap syndrome, quality of life, neurocognitive function, sleepiness, elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Mar 2016 (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.
Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.
Detailed description
OBJECTIVE: Describe the clinical and physiological characteristics of obstructive sleep apnea (OSA) and comorbid chronic obstructive pulmonary disease (COPD) and study the impact of treatment on neurocognitive outcomes in elderly Veterans.
RESEARCH PLAN: The investigators will study if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness with reduced quality of life compared to patients with either OSA or COPD alone (Aim 3) and whether treatment with PAP/NIPPV and supplemental oxygen compared to CPAP alone in elderly Veterans with moderate-to-severe OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness and quality of life (QoL).
Aim A: To determine if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness compared to patients with either OSA or COPD.
Hypothesis: Elderly veterans (age 60 years) with moderate-to-severe OSA and concomitant moderate-to-severe COPD will have significantly increased cognitive deficits and daytime sleepiness compared with similar patients with OSA alone or COPD alone.
To study this aim the investigators will prospectively administer and compare the results of a battery of cognitive tests, and sleepiness and QoL questionnaires in elderly patients with OSA, COPD, and the Overlap Syndrome.
Aim B. To determine if treatment with PAP/NIPPV and/or supplemental oxygen compared to CPAP alone in elderly Veterans with OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness, and QoL.
Hypothesis: Therapy with PAP and supplemental oxygen will reverse neurocognitive deficits in one or more domains, reduce sleepiness, and improve QoL compared with CPAP alone in patients with moderate-to-severe OSA and concomitant moderate COPD. This aim will evaluate which specific deficits in neurocognitive function in patients with moderate-to-severe Overlap Syndrome are reversible and most sensitive to the effects of positive airway pressure (PAP) and oxygen vs CPAP alone.
To study this aim the investigators will randomize patients with the Overlap Syndrome to 3months of therapy with PAP and/or oxygen vs CPAP alone for 3 months and evaluate impact on neurocognitive function, sleepiness and quality of life before and after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive airway pressure therapy | Active comparator | Device: Positive airway pressure, Device: NIPPV and /or oxygenControl group patients will receive standard care with PAP- positive airway pressure. |
| COPD | No intervention | –The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria. |
| OSA and comorbid COPD | No intervention | –Eligible elderly (age >/=60yrs) Veterans with moderate to severe Overlap Syndrome. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15* per hour by polysomnography
- Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio <70% and FEV1 >30% and <80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking
- Age 60 years
- Male or female gender
Key exclusion criteria (22 listed)
- Mild COPD
- Mild OSA
- Overlap Syndrome with mild OSA plus mild COPD
- Central sleep apnea defined as central apnea index >5 per hour
- Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
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 |
|---|---|---|
| Positive airway pressureAlso: Standard of care control armCPAP will be applied as standard of care for diagnosis of moderate to severe OSA | Device | Positive airway pressure therapy |
| NIPPV and /or oxygenAlso: Active interventionsupplemental oxygen will be applied to PAP/non-invasive positive pressure therapy | Device | Positive airway pressure therapy |
Primary outcome
Neurocognitive function
Time frame: Change from baseline neurocognitive function at 3 months
The neurocognitive test - Trails A test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Sleepiness
Time frame: Change from baseline sleepiness at 3 months
Epworth Sleepiness Scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome.
Quality of life (Short-Form survey)
Time frame: Change from baseline quality of life at 3 months
Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome.
Neurocognitive test
Time frame: Change from baseline at 3 months
The neurocognitive test - Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive test (Paced Auditory Serial Addition Test)
Time frame: Change from baseline at 3 months
The neurocognitive test: Paced Auditory Serial Addition Test (PASAT) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.
Neurocognitive test (Stroop Color-Word Interference)
Time frame: Change from baseline at 3 months
The neurocognitive test: Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive test (DIGIT test)
Time frame: Change from baseline at 3 months
The neurocognitive DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive test (Wechsler Abbreviated Scale of Intelligence)
Time frame: Change from baseline at 3 months
The neurocognitive test: abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Quality of life (Functional Outcomes of Sleep Questionnaire)
Time frame: Change from baseline quality of life at 3 months
Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ)-10. There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.
Quality of life (St. George's Respiratory Questionnaire)
Time frame: Change from baseline quality of life at 3 months
Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.
5 secondary outcomes
Dyspnea
Time frame: Change from baseline at 3 months
Hours of nightly positive airway pressure (PAP) use/NIPPV use
Time frame: 90 days after start of therapy
Hours of nightly oxygen use
Time frame: 3 months after start of therapy
Borg scale
Time frame: Change from baseline at 3 months
Blood pressure
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- 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.
Susmita Chowdhuri, MD MS principal investigator
John D. Dingell VA Medical Center, Detroit, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive airway pressure and NIPPV and /or oxygen in people with Obstructive Sleep Apnea and OSA COPD Overlap Syndrome, run by VA Office of Research and Development 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 4 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruchi Rastogi, MS ((313) 576-4464, ruchi.rastogi@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive function (time frame: Change from baseline neurocognitive function at 3 months). The study lists 10 primary outcomes in all. 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 26 May 2026.