Diabetes Sleep Treatment Trial for Insomnia

Study Overview
=================
Brief Summary
-----------------
This study will test the effect of the an insomnia intervention with cognitive behavioral treatment delivered via web compared with an information control group on glucose control and self management behavioral in a sample of persons with type 2 diabetes (T2DM).

Detailed Description
-----------------
Recent evidence supports that insomnia is a prevalent problem among persons with type 2 diabetes that may be associated with increased daytime sleepiness and fatigue, increased diabetes-related distress, decreased self-management behavior, and worse glycemic control. The main hypothesis of the current application is that a web-based cognitive behavioral treatment of insomnia (Sleep Health Using the Internet: SHUTi) in persons with T2DM will not only improve their nighttime sleep, but also improve their ability to integrate diabetes education into their daily behavior and positively affect their glucose control compared to a web-based Information Control (IC) group. The aims of this study are to 1) obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a randomized clinical trial to examine if treatment of insomnia results in participant's being better able to integrate diabetes education into their self-management behavior and result in improved glucose control, 2) explore the associations among changes in insomnia severity, fatigue, daytime sleepiness, sleep quality, A1C (a measure of glucose control over the last three months) and diabetes self-management (DSM) behaviors, 3) explore average pre-intervention to post-intervention changes in insomnia severity, daytime symptoms (fatigue, sleepiness, mood) and DSM behaviors (diet and physical activity) in subjects treated with SHUTi + DSM compared to IC + DSM subjects at 3 months, and 4) explore sleep fragmentation as a potential physiological mechanism linking impaired glucose control (A1C) and sleep in subjects with insomnia and T2DM at baseline and 3 months.

Official Title
-----------------
Self-Management, Insomnia, and Glucose Control in Adults With Diabetes

Conditions
-----------------
Insomnia, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Insomnia Intervention
* Other: Information Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) T2DM with suboptimal glucose control (2) age 18 years or older; (3) willing to be randomized to SHUTi or IC group; (4) able to speak, read, and write in English, and (5) insomnia symptoms with at least one daytime consequence [e.g. impaired mood, poor sleep quality, excessive daytime sleepiness, fatigue]. Exclusion Criteria: Type 1 or gestational diabetes Change in oral medications or > 10% change in insulin in last 3 months Acute medical or psychiatric illness or hospitalization ≤ 3 months (such as angina, stroke, major surgery, major depression or serious psychiatric conditions) AHI (apnea-hypopnea index; apnea [cessation of breathing] or hypopnea [reduction in breathing]) ≥ 10 episodes an hour on overnight sleep study Non-ambulatory Self-reported epilepsy, psychotic or bipolar disorder History of near-miss or auto accident during last 12 months Employed in safety sensitive job (e.g. truck driver or airline pilot) Working nights or rotating shifts Regular use of alerting (e.g., modafinil) medications Consumption of alcohol: Men: > 4 drinks a day or > 14 drinks per week Women: > 3 drinks a day or > 7 drinks per week If using sleep medications, the drug and/or dose changed in the past month Depression Medications for psychotic or bipolar disorders No internet access Pregnant or intend to become pregnant in the next four months (postmenopausal or confirmed not pregnant by a urine pregnancy test)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insomnia Intervention<br>Insomnia intervention delivered via web using Cognitive Behavior Treatment | Behavioral: Insomnia Intervention<br>* The SHUTi intervention is based on a cognitive behavioral treatment for insomnia (CBT-I) and organized into six structured, weekly online sessions. Each week the participants will complete a 30-minute interactive learning module and to complete daily online sleep diaries will be used.<br>|
| Other: Information Control<br>General health information website | Other: Information Control<br>* Information on websites that are general health promoting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Glucose Control for Last 3 Months Assessed by A!C level | A1C level | After 12 weeks of either the insomnia intervention or the information control intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Scores on the Pittsburgh Sleep Quality Index questionnaire | After 12 weeks of either the insomnia intervention or the information control intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive behavioral treatment