An interventional study of CBT-I and sleep hygiene in Insomnia and Insulin Resistance, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
Among 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia — 4 open to participants now, 5 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · University of Missouri-Columbia.
Among the 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia, this one is the 16th largest by planned enrollment, is the only one that started in 2026, is one of 18 with no phase, and was the 17th registered.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →4 of the 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia are open now, in 1 country. Recruiting first, the newest first:
University of Missouri-Columbia · Sites in United States
University of Missouri-Columbia · Sites in United States
University of Missouri-Columbia
By country, each count listing its studies:
Of the 386 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 204 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
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18 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 20 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 59 across the 18 interventional studies. Of the 11 that completed or were terminated, 3 (27%) have results posted.
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University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.
2 of the studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04253691University of Missouri-ColumbiaSleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study | 2026-12-30 |
| NCT07333586University of Missouri-ColumbiaInsomnia and Insulin Resistance | 2027-06-01 |
Among the 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ages 18-50 y 28-45 kg/m2 Score on the Insomnia Severity Index ≥15.
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment with cognitive behavior therapy for insomnia this is behaviorial therapy that meets with a "coach" once a week for 5 wk
Behavioral: CBT-I
treatment with sleep hygiene group meets with a coach once at the beginning of the intervention period
Behavioral: sleep hygiene
meets with "coach" who is teaching the participant how to deal with insomnia meets 5 times/once a week with the coach
meets with coach 1 time and is teaching the participant how to improve their sleep
insulin resistance
HOMA-IR calculation
Time frame: baseline and through study completion, an average of 9 weeks
sleep duration
measuring sleep duration with Actigraph
Time frame: baseline and through study completion, an average of 9 weeks
Plan to share: Yes
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 8 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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