Diabetes Sleep Treatment Trial for Insomnia (DSTT-I)

University of Pittsburgh

Status

Completed

Conditions

Insomnia

Diabetes Mellitus, Type 2

Treatments

Other: Information Control

Behavioral: Insomnia Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03064321

K24NR016685-01A1

Details and patient eligibility

About

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).

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)