InsomniaNCT07333586
Insomnia and Insulin Resistance
A study testing CBT-I and sleep hygiene in people with Insomnia and Insulin Resistance, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. Chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Insulin Resistance
- What is being tested?
- CBT-I and sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2026to 1 Jun 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-50 y BMI 28-45 kg/m2 Score on the Insomnia Severity Index ≥15.
Who cannot join
- contraindications for CBT-I (mania or seizure disorder) symptoms requiring immediate attention (e.g., psychosis, suicide intent) report illicit substance use on a monthly basis (e.g., cocaine, opioids) receiving behavioral treatment for insomnia overt cardiovascular disease overt renal disease thyroid disease cancer pregnant dieting using GLP-1 agonists taking exogenous insulin
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
University of Missouri
Columbia, Missouri, 65211
Jill A Kanaley, PhD, 573-772-2519, kanaleyj@missouri.edu
Jill Kanaley
About this study
Official title: Insomnia, Metabolic Syndrome and Insulin Resistance
Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. Chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States. The recommended first line of treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a multidimensional treatment that targets the thoughts and behaviors that perpetuate insomnia symptoms over time. This study will explore CBT-I effects on MetS outcomes (ie. blood pressure, triglycerides, etc.) and provide preliminary evidence that CBT-I impacts IR and fasting glucose concentrations within this population.
20 subjects with insomnia will be recruited. They will be randomly assigned to either CBT-i or sleep hygiene. The intervention is 5 wks. Pre and post intervention, the investigator will have participants fill out a number of questionnaires, a daily sleep diary, 2 weeks of actigraphy measuring sleep and physical activity and there will be a single blood draw at the beginning and the end of the study.
Read the detailed description
Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. In young healthy individuals, shortened sleep duration results in IR and elevated free fatty acid concentrations and has been associated with circadian misalignment. Additionally, individuals with type 2 diabetes (T2D) frequently have insufficient sleep or poor sleep quality, and greater sleep disturbances are associated with poorer glycemic control. Thus chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States, impacting at least 10% of the general population and ~40% of those with T2D. Although stress or changes in lifestyle habits often cause short-term insomnia, chronic insomnia (Insomnia Disorder) is defined as difficulty falling or staying asleep that causes daytime impairment 3 or more nights a week, lasts 3 or more months, and cannot be fully explained by another health problem.
The recommended first line of treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a multidimensional treatment that targets the thoughts and behaviors that perpetuate insomnia symptoms over time. The cognitive components of the therapy empower patients to challenge their automatic thoughts and reactions to poor sleep, and the behavioral components focus on matching time in bed to sleep ability in order to increase homeostatic sleep drive (or natural propensity for sleep). CBT-I improves insomnia in many populations (e.g., among those with psychological and physical comorbidities, chronic pain, etc). CBT-I has also demonstrated efficacy in reducing insomnia symptoms among those with IR in two pilot studies, but no studies have been powered to test CBT-I effects on metabolic outcomes within this population.
Obesity is a leading risk factor for impaired metabolic health. Given the impact of insomnia symptoms on MetS, effective treatment of insomnia may improve metabolic outcomes among those with obesity. This study aims to:
- Demonstrate the feasibility of the proposed CBT-I protocol. Specifically, the investigators hypothesize that ≥85% of participants will complete all assigned treatment sessions and follow-ups.
- Replicate previous findings that CBT-I reduces insomnia among obese adults with insomnia.
- Explore CBT-I effects on MetS outcomes (ie. blood pressure, triglycerides, etc.).
- Provide preliminary evidence that CBT-I impacts IR and fasting glucose concentrations within this population.
20 subjects with insomnia will be recruited. Participants will be randomly assigned to either CBT-i or sleep hygiene. The intervention is 5 wks. Pre and post intervention, the investigators will have participants fill out a number of questionnaires, a daily sleep diary, 2 weeks of actigraphy measuring sleep and physical activity and there will be a single blood draw at the beginning and the end of the study.
- Conditions
- Insomnia, Insulin Resistance
- Being tested
- CBT-I, sleep hygiene
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
meets with "coach" who is teaching the participant how to deal with insomnia meets 5 times/once a week with the coach
sleep hygieneBehavioural
meets with coach 1 time and is teaching the participant how to improve their sleep
| Study group | Role | What they receive |
|---|---|---|
| CBT-1 | Active comparator | treatment with cognitive behavior therapy for insomnia this is behaviorial therapy that meets with a "coach" once a week for 5 wk Receives: Behavioral: CBT-I |
| sleep hygiene | Placebo comparator | treatment with sleep hygiene group meets with a coach once at the beginning of the intervention period Receives: Behavioral: sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
HOMA-IR calculation
Measured: baseline and through study completion, an average of 9 weeks
Secondary outcomes (1)
sleep duration
measuring sleep duration with Actigraph
Measured: baseline and through study completion, an average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Sep 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333586
- Sponsor's protocol ID
- insomnia
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia, Metabolic Syndrome and Insulin Resistance
- ClinicalTrials.gov ID
- NCT07333586
- Acronym / sponsor ID
- insomnia
- Conditions
- Insomnia, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 20 Sep 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Jan 2026 (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.
Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. Chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States. The recommended first line of treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a multidimensional treatment that targets the thoughts and behaviors that perpetuate insomnia symptoms over time. This study will explore CBT-I effects on MetS outcomes (ie. blood pressure, triglycerides, etc.) and provide preliminary evidence that CBT-I impacts IR and fasting glucose concentrations within this population.
20 subjects with insomnia will be recruited. They will be randomly assigned to either CBT-i or sleep hygiene. The intervention is 5 wks. Pre and post intervention, the investigator will have participants fill out a number of questionnaires, a daily sleep diary, 2 weeks of actigraphy measuring sleep and physical activity and there will be a single blood draw at the beginning and the end of the study.
Detailed description
Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. In young healthy individuals, shortened sleep duration results in IR and elevated free fatty acid concentrations and has been associated with circadian misalignment. Additionally, individuals with type 2 diabetes (T2D) frequently have insufficient sleep or poor sleep quality, and greater sleep disturbances are associated with poorer glycemic control. Thus chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States, impacting at least 10% of the general population and ~40% of those with T2D. Although stress or changes in lifestyle habits often cause short-term insomnia, chronic insomnia (Insomnia Disorder) is defined as difficulty falling or staying asleep that causes daytime impairment 3 or more nights a week, lasts 3 or more months, and cannot be fully explained by another health problem.
The recommended first line of treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a multidimensional treatment that targets the thoughts and behaviors that perpetuate insomnia symptoms over time. The cognitive components of the therapy empower patients to challenge their automatic thoughts and reactions to poor sleep, and the behavioral components focus on matching time in bed to sleep ability in order to increase homeostatic sleep drive (or natural propensity for sleep). CBT-I improves insomnia in many populations (e.g., among those with psychological and physical comorbidities, chronic pain, etc). CBT-I has also demonstrated efficacy in reducing insomnia symptoms among those with IR in two pilot studies, but no studies have been powered to test CBT-I effects on metabolic outcomes within this population.
Obesity is a leading risk factor for impaired metabolic health. Given the impact of insomnia symptoms on MetS, effective treatment of insomnia may improve metabolic outcomes among those with obesity. This study aims to:
- Demonstrate the feasibility of the proposed CBT-I protocol. Specifically, the investigators hypothesize that ≥85% of participants will complete all assigned treatment sessions and follow-ups.
- Replicate previous findings that CBT-I reduces insomnia among obese adults with insomnia.
- Explore CBT-I effects on MetS outcomes (ie. blood pressure, triglycerides, etc.).
- Provide preliminary evidence that CBT-I impacts IR and fasting glucose concentrations within this population.
20 subjects with insomnia will be recruited. Participants will be randomly assigned to either CBT-i or sleep hygiene. The intervention is 5 wks. Pre and post intervention, the investigators will have participants fill out a number of questionnaires, a daily sleep diary, 2 weeks of actigraphy measuring sleep and physical activity and there will be a single blood draw at the beginning and the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-1 | Active comparator | Behavioral: CBT-Itreatment with cognitive behavior therapy for insomnia this is behaviorial therapy that meets with a "coach" once a week for 5 wk |
| sleep hygiene | Placebo comparator | Behavioral: sleep hygienetreatment with sleep hygiene group meets with a coach once at the beginning of the intervention period |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ages 18-50 y BMI 28-45 kg/m2 Score on the Insomnia Severity Index ≥15.
Key exclusion criteria (1 listed)
- contraindications for CBT-I (mania or seizure disorder) symptoms requiring immediate attention (e.g., psychosis, suicide intent) report illicit substance use on a monthly basis (e.g., cocaine, opioids) receiving behavioral treatment for insomnia overt cardiovascular disease overt renal disease thyroid disease cancer pregnant dieting using GLP-1 agonists taking exogenous insulin
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 |
|---|---|---|
| CBT-Imeets with "coach" who is teaching the participant how to deal with insomnia meets 5 times/once a week with the coach | Behavioural | CBT-1 |
| sleep hygienemeets with coach 1 time and is teaching the participant how to improve their sleep | Behavioural | sleep hygiene |
Primary outcome
insulin resistance
Time frame: baseline and through study completion, an average of 9 weeks
HOMA-IR calculation
1 secondary outcome
sleep duration
Time frame: baseline and through study completion, an average of 9 weeks
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I and sleep hygiene in people with Insomnia and Insulin Resistance, run by University of Missouri-Columbia 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 1 inclusion and 1 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 24 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jill A Kanaley, PhD (5737722519, kanaleyj@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance (time frame: baseline and through study completion, an average of 9 weeks). 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 24 Sep 2026.