Deprescribing for Sleeplessness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh, PA
Sleeplessness+1 More
Deprescribing - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a digital intervention can help Veterans stop using sedative-hypnotics and improve sleep.

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Eligible Conditions

  • Sleeplessness
  • Insomnia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Deprescribing will improve 2 primary outcomes and 4 secondary outcomes in patients with Sleeplessness. Measurement will happen over the course of baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24).

Month 3
Insomnia Severity Index (ISI) Change
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Sedative-Hypnotic Medication Use Change
Sleep Diary - Sleep Efficiency Change
Sleep Diary - Sleep Onset Latency (SOL) Change
Sleep Diary - Wake After Sleep Onset (WASO) Change

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

COAST + Deprescribing
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Deprescribing is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

COAST + DeprescribingCBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (t0; week 0), post-treatment (t1; week 12), 3 month follow-up (t2; week 24)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (t0; week 0), post-treatment (t1; week 12), 3 month follow-up (t2; week 24) for reporting.

Closest Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A Veteran receiving care at VA Pittsburgh Healthcare System
Active sedative-hypnotic medication use >14 days/month for >=3 months
A desire to reduce or stop using sedative-hypnotic medications
Access to a mobile device with internet

Patient Q&A Section

How many people get sleeplessness a year in the United States?

"Among an adult population, approximately 16.0% to 20.5% report getting sleeplessness a year. The strongest factors for reporting sleeplessness were being female and young. For patients who report sleeplessness, insomnia, fatigue, or feeling tired as the main complaint, the need for sleep, or fatigue and feeling tired all contributed significantly to a poor sleep quality or quantity." - Anonymous Online Contributor

Unverified Answer

What causes sleeplessness?

"Sleep quality is related to psychological factors, including stress, and psychosocial factors, including social deprivation. Sleep quality may also be influenced by circadian rhythms, circadian disruption, and sleep hygiene." - Anonymous Online Contributor

Unverified Answer

Can sleeplessness be cured?

"Sleeplessness has not been found to be a treatable condition. Therefore, therapy for sleeplessness should focus on reducing the cause.\nquestion: Can a person be cured? answer: When people were given the task to cure themselves of insomnia, most refused or could not complete the task. While the desire to cure oneself of insomnia may be strong, it seems impossible to permanently curb that desire." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleeplessness?

"Sleeplessness is treated by a variety of medications. These medications include sedative-hypnotics and anticholinergic agents. Medications used for sleep maintenance can include prescription sleep aids, melatonin, and non-benzodiazepine z-drugs (e.g., zolpidem). Many patients rely on a combination of pharmacotherapy as well as CBT to improve their sleep. Patients in remission are better able to sleep at sleep onset. Cognitive behavioral therapy may also improve somnolence in some patients, even in patients on chronic medications." - Anonymous Online Contributor

Unverified Answer

What is sleeplessness?

"Sleeping for long hours without rest may be a predictor of future morbidity in children and adolescents. In addition, sleeping a smaller amount of time in comparison to other people of the same age could be a disadvantage. In order to know whether a condition is caused by a sleeping or a sleeping behavior, a doctor or psychologist could help you to see the sleeping pattern on a sleep history for more than 2 months. A doctor or psychologist may also help you to find a sleep disorder by making sure your sleeping habits have no correlation with your medical conditions. Also, the type of sleep disorder includes narcolepsy, sleep apnea, hypersomnia, or restless sleep." - Anonymous Online Contributor

Unverified Answer

What are the signs of sleeplessness?

"Recent findings shows that insomnia is a common sleep problem in patients with asthma and that insomnia is frequently associated with depressed mood. Sleeplessness should be considered a possible symptom and treated because it may be treatable." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating sleeplessness?

"The evidence from this review suggests the existence of significant gaps in our knowledge about the underlying mechanisms of sleep in both disease and in normal wakefulness." - Anonymous Online Contributor

Unverified Answer

Is deprescribing safe for people?

"While a small percentage of people did not report that they did not forget to take their medication, this information could help doctors and patients remember to take their medication." - Anonymous Online Contributor

Unverified Answer

What is deprescribing?

"These patients are living with chronic and recurrent pain and other problems that do not improve with medications. The doctors are prescribing treatments based on patients' previous experiences or expectations of treatment, without having a clear definition of what deprescribing entails. A better understanding of patient perceptions and expectations in this group of patients may aid physicians in making better medical decisions." - Anonymous Online Contributor

Unverified Answer

What does deprescribing usually treat?

"Deprescribing usually treats the conditions for which patients have been on the medications. A few patients did not receive a therapeutic dose and had no change in clinical status or adverse events. It is crucial that prescribers monitor patients on drugs commonly de-prescribed." - Anonymous Online Contributor

Unverified Answer

How serious can sleeplessness be?

"Overall, patients with insomnia have greater insomnia symptoms and more adverse consequences, perhaps because their sleep is interrupted and their wake times are irregular. These data raise concerns about the long-term consequences of insomnia." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in deprescribing for therapeutic use?

"This article focuses on new research developments in the deprescribing of antidepressants in older people. Many older adults live with depressive symptoms and chronic illnesses, which may worsen their health-related quality of life. Current clinical guidelines provide evidence-based assessments. Clinicians can then decide to deprescribe based on the patient's preferences and the patient's goals of care." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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