Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Официальное название

Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Обзор

This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.

Подробное описание

Type 2 diabetes mellitus (T2D) is a major cause of blindness, kidney failure, cardiovascular disease, amputations, reduced quality of life, and premature death in the United States, and it is expected that one in three Americans will have T2D by 2050. To stem the tide of this health crisis, new strategies are needed to prevent the progression to T2D from prediabetes-elevated glucose levels that are not yet in the diabetes range. A growing body of research suggests that insomnia is a major modifiable risk factor for progression to diabetes. The proposed study would build off a promising feasibility study to test whether providing cognitive behavioral therapy for insomnia (CBT-I) to patients with prediabetes results in a reduction in glucose levels compared to a patient education control program. If so, this insomnia treatment could be an effective tool to prevent diabetes.

Individuals with prediabetes and insomnia will be randomized to receive six sessions of a deployment-ready digital CBT-I program, providing standard-of-care treatment for insomnia (intervention arm, n = 150), or a patient education website providing nontailored material about insomnia (control arm, n = 150). The investigators will complete assessments at baseline, at 11 weeks (after the conclusion of the intervention and control programs), and at 33 weeks post-baseline, measuring hyperglycemia, objective and subjective measures of sleep, and potential mediating variables including diet, exercise, and mood.

The investigators will assess (1) whether individuals randomized to the intervention arm have lower rates of hyperglycemia, as measured by oral glucose tolerance testing and various secondary measures, than individuals randomized to the control arm at 11 weeks and 33 weeks after baseline; (2) whether improvements in sleep after baseline are associated with decreases in hyperglycemia, regardless of study arm; and (3) whether any effects of the intervention on hyperglycemia are mediated by improvements in sleep, diet, exercise, and/or mood.

This research will serve as a critical step in identifying a potentially dramatic tool for improving health outcomes for Americans at risk of T2DM. Sleep interventions can lead to sustained improvements that are intrinsically rewarding to patients. If effective, digital CBT-I could provide a powerful pathway to preventing diabetes for millions of patients with prediabetes.

Вмешательства

• Другое SHUTi
  Each core includes a variety of interactive features, such as animations, vignettes, "myth" and "reality" buttons that reveal common misperceptions and facts about sleep, "learn more" buttons that provide in-depth information about a topic, and quizzes. All cores follow a similar structure with objectives, main content, homework, and review. Participants are free to revisit cores as many times as they like.
• Другое Patient Education
  The PE website will present content in a simple, static form, without interactive components; and all content on the website will be provided at once, rather than in modules that unlock over time. The PE website will also not provide personalized or individually tailored treatment recommendations.

Первичные конечные точки

• 2-hour post-load glucose (2hPG) (mg/dL) [Срок оценки: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]

Вторичные конечные точки (4)

• Hemoglobin A1c (A1C) (percentage) [Срок оценки: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]
• Fasting plasma glucose (FPG) (mg/dL) [Срок оценки: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]
• Mean glucose on CGM (mg/dL) [Срок оценки: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]
• Insulin resistance score (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L) [Срок оценки: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]

Критерии участия

Критерии включения

• Age ≥ 22 years and < 80 years of age
• Prediabetes
• Insomnia
• Regular access to device with internet access
• Adequate data at baseline

Критерии исключения

• BMI > 40 kg/m2
• Sleep comorbidities detected in medical record or via medical history
• Shift work or significant, externally imposed irregular sleep schedule
• moderate to severe OSA by home sleep apnea test as part of trial protocol
• Received a full course of CBT-I in the last 12 months
• Current use of medication with glycemic effects:
• History of type 1 or type 2 diabetes or recent/planned use of hypoglycemic agents (e.g., metformin, insulin)
• Recent history of bariatric surgery or planning bariatric surgery in the next year
• Current or recent use of weight loss meds
• Unstable sleep medication regimen (recent change to schedule or dosage)
• Significant comorbidity that may interfere with CBT-I uptake or increase risks
• Unwilling or unable to limit heavy machinery use/long bouts of driving or unstable illness that would be worsened by sleep restriction
• High risk of falls
• Epilepsy
• Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use)
• Significant alcohol or substance use disorder
• Active or recent history of eating disorder, recent weight change of >10%
• Women: pregnancy (current or planned), breastfeeding, < 1 year postpartum
• Use of hydroxyurea
• Extensive skin changes or adhesive allergy making CGM sensor use problematic

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kaiser Permanente Center for Health Research — Portland

Публикации

• Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9. PMID 22683128
• Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, PMID 31992061
• Centers for Disease Control and Prevention. Diabetes Report Card 2014. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services, 2015.
• LeBlanc ES, Smith NX, Nichols GA, Allison MJ, Clarke GN. Insomnia is associated with an increased risk of type 2 diabetes in the clinical setting. BMJ Open Diabetes Res Care. 2018 Dec 26;6(1):e000604. doi: 10.1136/bmjdrc-2018-000604. eCollection 2018. PMID 30687505
• Anothaisintawee T, Reutrakul S, Van Cauter E, Thakkinstian A. Sleep disturbances compared to traditional risk factors for diabetes development: Systematic review and meta-analysis. Sleep Med Rev. 2016 Dec;30:11-24. doi: 10.1016/j.smrv.2015.10.002. Epub 2015 Oct 21. PMID 26687279
• Cappuccio FP, D'Elia L, Strazzullo P, Miller MA. Quantity and quality of sleep and incidence of type 2 diabetes: a systematic review and meta-analysis. Diabetes Care. 2010 Feb;33(2):414-20. doi: 10.2337/dc09-1124. Epub 2009 Nov 12. PMID 19910503
• Hatoum HT, Kania CM, Kong SX, Wong JM, Mendelson WB. Prevalence of insomnia: a survey of the enrollees at five managed care organizations. Am J Manag Care. 1998 Jan;4(1):79-86. PMID 10179908
• Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8. PMID 10543671

Идентификаторы

NCT: NCT06067139 · R01DK132229 · 1R01DK132229-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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