InsomniaSHADESNCT06041581
SHADES Mechanistic Trial
A study testing Sleep Healthy Using The Internet (SHUTi), Telephonic CBT-I and Face-to-Face CBT-I in people with Insomnia and Insomnia Chronic, run by Indiana University at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia represent a large group of people at elevated risk of developing CVD in the future. This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Insomnia, Insomnia Chronic, Insomnia, Primary
- What is being tested?
- Sleep Healthy Using The Internet (SHUTi), Telephonic CBT-I and Face-to-Face CBT-I
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to 31 Jul 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current primary care patient in Eskenazi Health
- Age ≥40 years
- Current insomnia disorder: During screening, ResNet assistants will administer the Insomnia Severity Index (ISI), a validated screener in primary care. Patients who have ISI scores ≥10 (97% sensitivity, 64% specificity) and remain eligible after ResNet screening will be called by our Insomnia Clinical Specialist, who will administer the Structured Clinical Interview for DSM-5 Sleep Disorders to confirm insomnia disorder.
- Elevated CVD risk: Elevated CVD risk will be defined as ≥2 (if 40-59 years) or ≥1 (if 60+ years) of the following risk factors in the Eskenazi Health EHR in the past 5 years: hypertension, hypercholesterolemia, diabetes, or smoking.
Who cannot join
- History of clinical CVD: a self-reported CVD diagnosis during screening or any of the following in the patient's electronic health record before enrollment: myocardial infarction, unstable angina, coronary artery disease, cerebrovascular disease, heart failure, percutaneous coronary intervention, or coronary artery bypass graft
- Sleep disorder diagnosis other than insomnia (e.g., sleep apnea)
- Continuous positive airway pressure (CPAP) use or a STOP-BANG Questionnaire score ≥5, which is indicative of high probability of sleep apnea
- A schedule requiring a usual bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am
- Major inflammatory conditions (HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or active cancer)
- Current pregnancy
Show all 9Show fewer
- Severe cognitive impairment (≥3 errors on a validated 6-item cognitive screen)
- History of bipolar disorder or psychosis
- Acute risk of suicide
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
Department of Psychology, School of Science, Indiana University Indianapolis
Indianapolis, Indiana, 46202
About this study
Official title: Strengthening Hearts by Addressing DisruptEd Sleep (SHADES) Mechanistic Trial
Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia represent a large group of people at elevated risk of developing CVD in the future. This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how insomnia promotes CVD and if these improvements are due to positive changes in sleep factors. A total of 200 primary care patients with insomnia and CVD risk factors will be randomized to 6 months of the SHADES intervention (internet, telephonic, and/or face-to-face cognitive-behavioral therapy for insomnia) or the active control condition (sleep education/hygiene, symptom monitoring, and primary care for insomnia). Before and after treatment, participants will complete measurements of the CVD factors (systemic inflammation, autonomic dysfunction, metabolic dysregulation, proinflammatory gene expression) and the sleep factors (insomnia symptoms, sleep onset latency, wake after sleep onset, sleep efficiency). Researchers will test whether the SHADES intervention produces greater improvements in the CVD factors than the active control condition.
Read the detailed description
Cardiovascular disease (CVD) affects nearly 1 in 2 U.S. adults, is the #1 killer of men and women, burdens disadvantaged groups, and has costs greater than any other condition. While these statistics highlight the importance of CVD prevention, current approaches have only partial effectiveness. This has created a need to identify new CVD prevention targets, their underlying mechanisms, and effective interventions. Insomnia, its candidate mechanisms, and insomnia treatment are strong candidates in this regard. Thirty years of evidence indicates that insomnia is an independent, clinically important, robust, and potentially causal and modifiable risk factor for CVD. In addition, biologically plausible mechanisms that could explain how insomnia promotes the development of CVD have been proposed, with the most strongly supported being systemic inflammation, autonomic dysfunction, and metabolic dysregulation. Because insomnia now receives limited attention in settings where CVD prevention occurs (e.g., primary care), there is a large cohort of patients with an unaddressed CVD risk factor (insomnia). This status quo and the strong state of the insomnia-to-CVD science create the current need for a well-powered, mechanistic trial to elucidate biological mechanisms underlying the insomnia-to-CVD relationship and the mechanisms of action of cognitive-behavioral therapy for insomnia (CBT-I), both of which are presently unknown. Therefore, we are conducting a mechanistic trial of 200 primary care patients (45% minority) with insomnia and CVD risk factors but no clinical CVD. Participants will be randomized to 6 months of the SHADES (Strengthening Hearts by Addressing DisruptEd Sleep) intervention or the active control condition. The SHADES intervention is our modernized collaborative care intervention consisting of well-established internet, telephonic, and/or face-to-face CBT-I. The active control condition consists of sleep education/hygiene, symptom monitoring, and primary care for insomnia. Our proposal has four aims - Aim 1: determine the effect of the SHADES intervention on our primary CVD mechanism of high-sensitivity CRP; Aim 2: determine the effect of the SHADES intervention on our secondary CVD mechanisms of systemic inflammation, autonomic dysfunction, and metabolic dysregulation; Aim 3: examine if 6-month improvements in upstream sleep mechanisms mediate the SHADES intervention effect on 6-month improvements in downstream CVD mechanisms; Exploratory Aim: explore the effect of the SHADES intervention on proinflammatory gene expression. This trial could generate the critical support for the mechanistic rationale and conceptual framework needed to justify the next-step phase III, multi-site clinical trial to determine the SHADES Intervention effect on CVD clinical outcomes, endpoints of great public health relevance, morbidity, and cost.
- Conditions
- Insomnia, Insomnia Chronic, Insomnia, Primary, Sleep Disturbance, Sleep Disorder, Cardiovascular Diseases
- Being tested
- Sleep Healthy Using The Internet (SHUTi), Telephonic CBT-I, Face-to-Face CBT-I, Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary Care
- Keywords
- Primary Care, Internet Interventions, Cognitive-Behavioral Therapy for Insomnia, Insomnia, Cardiovascular Diseases
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias, Sleep Wake Disorders, Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Stroke, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Healthy Using The Internet (SHUTi)Behavioural
Sleep Healthy Using The Internet (SHUTi) is an empirically supported internet intervention. It uses a fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. Each session has the same structure: objectives, sleep diary and homework review, new intervention material, homework assignment, and summary. SHUTi is enhanced through interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program. We provide basic tablet skills training and tablets with data plans when needed.
Telephonic CBT-IBehavioural
Telephonic CBT-I will be delivered by our insomnia clinical specialist following the highly cited treatment manual by Perlis et al. (2005). Sessions will occur weekly for 30-50 minutes. Telephonic CBT-I will be delivered from a central location - the Insomnia Clinical Specialist's office. Telephonic CBT-I has been shown to be acceptable, feasible, and effective, with effect sizes similar to face-to-face CBT-I.
Face-to-Face CBT-IBehavioural
Face-to-face CBT-I will be delivered by our insomnia clinical specialist following the highly cited treatment manual by Perlis et al. (2005). Sessions will occur weekly for 30-50 minutes. Face-to-face CBT-I will be delivered at the Insomnia Clinical Specialist's office. CBT-I is the clear first-line treatment for insomnia.
Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary CareOther
A designated trial research assistant will have two calls with each AC patient - one 45-minute call on insomnia education and one 45-minute call on sleep hygiene practices. The same research assistant will also call AC patients monthly to assess insomnia symptoms and will notify clinical staff to encourage additional care when indicated. AC patients will receive usual primary care for insomnia. The targeted clinics utilize a team care approach for behavioral health issues, as PCPs are supported by behavioral health clinicians and psychiatrists available for brief counseling and medication management. However, there is no routine screening for insomnia, and behavioral treatment for insomnia is typically limited to sleep hygiene practices.
| Study group | Role | What they receive |
|---|---|---|
| SHADES Intervention | Experimental | The SHADES intervention is a 6-month, modernized, collaborative care intervention in which a multidisciplinary team delivers established insomnia treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that harnesses technology to maximize access to and convenience of effective treatments and to minimize personnel, training, and space requirements. Our Intervention Team consists of an insomnia clinical specialist, a clinical behavioral sleep medicine and CBT-I delivery expert, a sleep research/medicine expert, and the patients' primary care providers. Treatments to be delivered are CBT-I in different modalities - internet, phone, and face-to-face - all of which are empirically supported. Receives: Behavioral: Sleep Healthy Using The Internet (SHUTi); Behavioral: Telephonic CBT-I; Behavioral: Face-to-Face CBT-I |
| Active Control | Active comparator | Active Control (AC) consists of sleep education and hygiene (study staff), symptom monitoring (study staff), and usual primary care for insomnia (clinical staff). Receives: Other: Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-Sensitivity C-Reactive Protein (hsCRP)
The primary outcome is 6-month change in hsCRP assessed by the Human CRP Quantikine ELISA (R\&D Systems). hsCRP is a circulating inflammation biomarker that is implicated in the pathophysiology of CVD and is a predictor of future CVD events.
Measured: Baseline, 6 months
Secondary outcomes (5)
Interleukin-6 (IL-6)
A secondary outcome is 6-month change in IL-6 assessed by the validated MSD MULTI-SPOT® Assay System and 5 plex Proinflammatory Panel 1 Human Kit. IL-6, a proinflammatory cytokine that stimulates production of CRP, is moderately correlated with CRP, and is predictive of future CVD events.
Measured: Baseline, 6 months
Pre-Ejection Period (PEP)
A secondary outcome is 6-month change in resting PEP, an index of sympathetic activation, which will be assessed following established guidelines. Autonomic dysfunction measures are predictors of future CVD events.
Measured: Baseline, 6 months
High-Frequency Heart Rate Variability (HF HRV)
A secondary outcome is 6-month change in resting HF-HRV, an index of parasympathetic activation, which will be assessed following established guidelines. Autonomic dysfunction measures are predictors of future CVD events.
Measured: Baseline, 6 months
Hemoglobin A1c (HbA1c)
A secondary outcome is 6-month change in HbA1c. HbA1c will be measured by an immunoturbidimetric method on a Randox Daytona Clinical Analyzer. HbA1c is the gold standard measure of glycemia. HbA1c is a predictor of CVD events.
Measured: Baseline, 6 months
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
A secondary outcome is 6-month change in HOMA-IR. HOMA-IR will be computed from fasting glucose (glucose oxidase method on a Randox Daytona Clinical Analyzer) and insulin (two antibody immunoassay on a Roche cobas e411 Analyzer). HOMA-IR is an established index of insulin resistance that correlates highly with the invasive euglycemic clamp. HOMA-IR is a predictor of CVD events.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start25 Apr 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eskenazi Health, Regenstrief Institute, Inc., University of Virginia, University of California, Los Angeles
- Responsible party
- Principal investigator, Jesse Stewart, Indiana University
- Investigators
- Jesse C Stewart, Ph.D., Principal investigator, Indiana University Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041581
- Sponsor's protocol ID
- 17650
- Other IDs
- R01HL165115
- Acronym
- SHADES
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Hearts by Addressing DisruptEd Sleep (SHADES) Mechanistic Trial
- ClinicalTrials.gov ID
- NCT06041581
- Acronym / sponsor ID
- SHADES / 17650
- Conditions
- Insomnia, Insomnia Chronic, Insomnia, Primary, Sleep Disturbance, Sleep Disorder, Cardiovascular Diseases
- Keywords
- Primary Care, Internet Interventions, Cognitive-Behavioral Therapy for Insomnia, Insomnia, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eskenazi Health, Regenstrief Institute, Inc., University of Virginia, University of California, Los Angeles
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- 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.
Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia represent a large group of people at elevated risk of developing CVD in the future. This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how insomnia promotes CVD and if these improvements are due to positive changes in sleep factors. A total of 200 primary care patients with insomnia and CVD risk factors will be randomized to 6 months of the SHADES intervention (internet, telephonic, and/or face-to-face cognitive-behavioral therapy for insomnia) or the active control condition (sleep education/hygiene, symptom monitoring, and primary care for insomnia). Before and after treatment, participants will complete measurements of the CVD factors (systemic inflammation, autonomic dysfunction, metabolic dysregulation, proinflammatory gene expression) and the sleep factors (insomnia symptoms, sleep onset latency, wake after sleep onset, sleep efficiency). Researchers will test whether the SHADES intervention produces greater improvements in the CVD factors than the active control condition.
Detailed description
Cardiovascular disease (CVD) affects nearly 1 in 2 U.S. adults, is the #1 killer of men and women, burdens disadvantaged groups, and has costs greater than any other condition. While these statistics highlight the importance of CVD prevention, current approaches have only partial effectiveness. This has created a need to identify new CVD prevention targets, their underlying mechanisms, and effective interventions. Insomnia, its candidate mechanisms, and insomnia treatment are strong candidates in this regard. Thirty years of evidence indicates that insomnia is an independent, clinically important, robust, and potentially causal and modifiable risk factor for CVD. In addition, biologically plausible mechanisms that could explain how insomnia promotes the development of CVD have been proposed, with the most strongly supported being systemic inflammation, autonomic dysfunction, and metabolic dysregulation. Because insomnia now receives limited attention in settings where CVD prevention occurs (e.g., primary care), there is a large cohort of patients with an unaddressed CVD risk factor (insomnia). This status quo and the strong state of the insomnia-to-CVD science create the current need for a well-powered, mechanistic trial to elucidate biological mechanisms underlying the insomnia-to-CVD relationship and the mechanisms of action of cognitive-behavioral therapy for insomnia (CBT-I), both of which are presently unknown. Therefore, we are conducting a mechanistic trial of 200 primary care patients (45% minority) with insomnia and CVD risk factors but no clinical CVD. Participants will be randomized to 6 months of the SHADES (Strengthening Hearts by Addressing DisruptEd Sleep) intervention or the active control condition. The SHADES intervention is our modernized collaborative care intervention consisting of well-established internet, telephonic, and/or face-to-face CBT-I. The active control condition consists of sleep education/hygiene, symptom monitoring, and primary care for insomnia. Our proposal has four aims - Aim 1: determine the effect of the SHADES intervention on our primary CVD mechanism of high-sensitivity CRP; Aim 2: determine the effect of the SHADES intervention on our secondary CVD mechanisms of systemic inflammation, autonomic dysfunction, and metabolic dysregulation; Aim 3: examine if 6-month improvements in upstream sleep mechanisms mediate the SHADES intervention effect on 6-month improvements in downstream CVD mechanisms; Exploratory Aim: explore the effect of the SHADES intervention on proinflammatory gene expression. This trial could generate the critical support for the mechanistic rationale and conceptual framework needed to justify the next-step phase III, multi-site clinical trial to determine the SHADES Intervention effect on CVD clinical outcomes, endpoints of great public health relevance, morbidity, and cost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHADES Intervention | Experimental | Behavioral: Sleep Healthy Using The Internet (SHUTi), Behavioral: Telephonic CBT-I, Behavioral: Face-to-Face CBT-IThe SHADES intervention is a 6-month, modernized, collaborative care intervention in which a multidisciplinary team delivers established insomnia treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that harnesses technology to maximize access to and convenience of effective treatments and to minimize personnel, training, and space requirements. Our Intervention Team consists of an insomnia clinical specialist, a clinical behavioral sleep medicine and CBT-I delivery expert, a sleep research/medicine expert, and the patients' primary care providers. Treatments to be delivered are CBT-I in different modalities - internet, phone, and face-to-face - all of which are empirically supported. |
| Active Control | Active comparator | Other: Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary CareActive Control (AC) consists of sleep education and hygiene (study staff), symptom monitoring (study staff), and usual primary care for insomnia (clinical staff). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current primary care patient in Eskenazi Health
- Age ≥40 years
- Current insomnia disorder: During screening, ResNet assistants will administer the Insomnia Severity Index (ISI), a validated screener in primary care. Patients who have ISI scores ≥10 (97% sensitivity, 64% specificity) and remain eligible after ResNet screening will be called by our Insomnia Clinical Specialist, who will administer the Structured Clinical Interview for DSM-5 Sleep Disorders to confirm insomnia disorder.
- Elevated CVD risk: Elevated CVD risk will be defined as ≥2 (if 40-59 years) or ≥1 (if 60+ years) of the following risk factors in the Eskenazi Health EHR in the past 5 years: hypertension, hypercholesterolemia, diabetes, or smoking.
Key exclusion criteria (9 listed)
- History of clinical CVD: a self-reported CVD diagnosis during screening or any of the following in the patient's electronic health record before enrollment: myocardial infarction, unstable angina, coronary artery disease, cerebrovascular disease, heart failure, percutaneous coronary intervention, or coronary artery bypass graft
- Sleep disorder diagnosis other than insomnia (e.g., sleep apnea)
- Continuous positive airway pressure (CPAP) use or a STOP-BANG Questionnaire score ≥5, which is indicative of high probability of sleep apnea
- A schedule requiring a usual bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am
- Major inflammatory conditions (HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or active cancer)
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 |
|---|---|---|
| Sleep Healthy Using The Internet (SHUTi)Sleep Healthy Using The Internet (SHUTi) is an empirically supported internet intervention. It uses a fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. Each session has the same structure: objectives, sleep diary and homework review, new intervention material, homework assignment, and summary. SHUTi is enhanced through interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program. We provide basic tablet skills training and tablets with data plans when needed. | Behavioural | SHADES Intervention |
| Telephonic CBT-ITelephonic CBT-I will be delivered by our insomnia clinical specialist following the highly cited treatment manual by Perlis et al. (2005). Sessions will occur weekly for 30-50 minutes. Telephonic CBT-I will be delivered from a central location - the Insomnia Clinical Specialist's office. Telephonic CBT-I has been shown to be acceptable, feasible, and effective, with effect sizes similar to face-to-face CBT-I. | Behavioural | SHADES Intervention |
| Face-to-Face CBT-IFace-to-face CBT-I will be delivered by our insomnia clinical specialist following the highly cited treatment manual by Perlis et al. (2005). Sessions will occur weekly for 30-50 minutes. Face-to-face CBT-I will be delivered at the Insomnia Clinical Specialist's office. CBT-I is the clear first-line treatment for insomnia. | Behavioural | SHADES Intervention |
| Active Control: Sleep Education/Hygiene, Symptom Monitoring, and Usual Primary CareA designated trial research assistant will have two calls with each AC patient - one 45-minute call on insomnia education and one 45-minute call on sleep hygiene practices. The same research assistant will also call AC patients monthly to assess insomnia symptoms and will notify clinical staff to encourage additional care when indicated. AC patients will receive usual primary care for insomnia. The targeted clinics utilize a team care approach for behavioral health issues, as PCPs are supported by behavioral health clinicians and psychiatrists available for brief counseling and medication management. However, there is no routine screening for insomnia, and behavioral treatment for insomnia is typically limited to sleep hygiene practices. | Other | Active Control |
Primary outcome
High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, 6 months
The primary outcome is 6-month change in hsCRP assessed by the Human CRP Quantikine ELISA (R\&D Systems). hsCRP is a circulating inflammation biomarker that is implicated in the pathophysiology of CVD and is a predictor of future CVD events.
5 secondary outcomes
Interleukin-6 (IL-6)
Time frame: Baseline, 6 months
Pre-Ejection Period (PEP)
Time frame: Baseline, 6 months
High-Frequency Heart Rate Variability (HF HRV)
Time frame: Baseline, 6 months
Hemoglobin A1c (HbA1c)
Time frame: Baseline, 6 months
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, 6 months
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 6 Aug 2026.
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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.
Jesse C Stewart, Ph.D. principal investigator
Indiana University Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Healthy Using The Internet (SHUTi), Telephonic CBT-I and Face-to-Face CBT-I in people with Insomnia and Insomnia Chronic, run by Indiana 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 4 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 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?
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?
High-Sensitivity C-Reactive Protein (hsCRP) (time frame: Baseline, 6 months). 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 6 Aug 2026.