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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03194802
Other study ID # H2017:066
Secondary ID
Status Completed
Phase N/A
First received June 19, 2017
Last updated March 13, 2018
Start date June 5, 2017
Est. completion date January 30, 2018

Study information

Verified date March 2018
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of the study are to determine whether an online drug tapering program can lead to successful drug tapering in hypnotic dependent insomnia and whether such tapering is associated with improved daytime functioning and sleep.


Description:

Insomnia is defined as difficulty with falling asleep, staying asleep, or early morning awakening. Chronic insomnia is estimated to affect 9-15% of the world's population. Lack of sleep increases a person's risk for many chronic diseases such as obesity, diabetes, cardiovascular disease, anxiety and depression. The two types of treatment available for chronic insomnia are cognitive behavioural therapy (CBT) and pharmacotherapy, the latter of which includes benzodiazepines and non-benzodiazepines.

The use of hypnotic medications is intended to be prescribed as a short-term treatment of one or two weeks, however this is not the case most of the time. Hypnotic abuse and dependency are prevalent issues that increase with advancing age. With the regular intake of these substances comes many adverse effects such as sedation, cognitive and psychomotor effects, falls and other accidents. Relative to non-drug users, cognitive events are 5.0 times more likely, psychomotor events are 3.0 times more likely, and daytime fatigue is 4.0 times more likely among drug users. Both non-benzodiazepines and benzodiazepines have the potential for dependency and withdrawal, although zolpidem and other non-benzodiazepine hypnotic agents have become the preferred drugs to manage insomnia due to the lower side effect profile. Withdrawal symptoms are associated with a rapid dose decrease or abrupt discontinuance of medication. These symptoms include rebound insomnia, anxiety, memory and concentration impairments and in severe states, psychotic symptoms, delirium and epileptic seizures.

A recent comparison of cost data associated with pharmacotherapy and cognitive behavioral therapy showed that CBT was significantly less costly than pharmacotherapy. Unfortunately, CBT is often not applied due to limited access to appropriately trained practitioners. The combination of equivalent efficacy, reduced costs, and favorable side-effect profile have made cognitive behavioural therapy (CBT) the preferred treatment for insomnia as evidenced by endorsements with the American Academy of Sleep Medicine. More recently, the delivery of CBT for insomnia has been enhanced to be provided through web-based portals. A number of web-based programs for insomnia have been developed with promising results. Some of these programs measured hypnotic use.

The effect size associated with online CBT (without drug tapering component) on reducing hypnotic drug use has been small, and these studies have employed a mix of participants, only some of whom are interested in tapering with variable levels of motivation. Studies comparing CBT plus drug tapering with drug tapering alone using booklets and in-person sessions have found that such interventions are moderately effective in reducing dosage and frequency of sleep medication usage.

The aims of the study are to determine whether an online drug tapering program (Sleeping without Pills; SWOP) can lead to successful drug tapering in hypnotic dependent insomnia (primary aim), and whether such tapering is associated with improved daytime functioning and sleep (secondary aims).


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date January 30, 2018
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

a) >= 18 years, b) access to high speed internet and computer, c) disturbance of sleep consisting of a delay in sleep onset, return to sleep or early morning awakening at least 3 nights/week for at least 3 months in duration, d) at least one symptom of daytime impairment, use of medication to promote sleep, e) use of medication to promote sleep (either <= 1mg lorazepam, <= .5mg clonazepam, <= 7.5mg zopiclone, <= 50 mg trazodone/amitriptyline, f) interested in medication tapering.

Exclusion Criteria:

a) shift work, b) head injury, c) acute crisis, d) seizure disorder, e) use of psychotropic drugs for problems other than sleep, f) use of medication interfering with sleep, g) recreational drug use, h) symptoms suggestive of alternative sleep disorder that is untreated, i) elevated use of alcohol (> 14 beverages/week for males, >12 beverages per week for females)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleeping Without Pills Program
Participants receive this program online and are asked to log in daily for 6 weeks.
Self-monitoring
Participants enter sleep diary data online daily for 6 weeks

Locations

Country Name City State
Canada Clinical Health Psychology Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug dose Dose (mg) of sleep medication 6 weeks
Primary Drug frequency Frequency of use of sleep medication 6 weeks
Secondary Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) maladaptive beliefs about sleep 6 weeks
Secondary Insomnia Severity Index Concern about sleep and daytime impairment 6 weeks
Secondary Multi-Dimensional Fatigue Inventory Daytime fatigue 6 weeks
Secondary Epworth Sleepiness Scale Daytime sleepiness 6 weeks
Secondary Work and Social Adjustment Scale Impact of sleep on work and living 6 weeks
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