Diabetes Sleep Treatment Trial for Insomnia

NCT ID: NCT03064321

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-03-30

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.

Conditions

Insomnia; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insomnia Intervention

Insomnia intervention delivered via web using Cognitive Behavior Treatment

Group Type: EXPERIMENTAL

Insomnia Intervention

Intervention Type: BEHAVIORAL

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.

Information Control

General health information website

Group Type: OTHER

Information Control

Intervention Type: OTHER

Information on websites that are general health promoting

Interventions

Insomnia Intervention

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.

Intervention Type: BEHAVIORAL

Information Control

Information on websites that are general health promoting

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Eileen R. Chasens

Associate Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eileen R Chasens

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

K24NR016685-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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