Diabetes Sleep Treatment Trial for Insomnia

Completed · Not applicable

Conditions studied: Insomnia, Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT03064321

Run by

University of Pittsburgh

People needed

18

Starts

2017-11-01

Expected to finish

2020-03-30

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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].

You may not qualify if…

• 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)

Where it is running

• University of Pittsburgh School of Nursing — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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