What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally well-tolerated with minimal side effects, primarily involving temporary increases in anxiety or frustration as patients adjust to new sleep habits. In contrast, pharmacological treatments for chronic insomnia, such as benzodiazepines and nonbenzodiazepine receptor agonists (e.g., zolpidem), can cause side effects including drowsiness, confusion, gait instability, and risk of dependency. Melatonin, another common treatment, is generally safe but may cause dizziness, headaches, or daytime drowsiness in some individuals.

What prior FDA approvals exist?

The FDA has approved various pharmacologic treatments for chronic insomnia, including medications like eszopiclone, zolpidem, and other nonbenzodiazepine benzodiazepine receptor agonists. However, Cognitive Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacologic treatment that has shown significant effectiveness in improving sleep quality and is being studied in digital formats, such as the Prescription Digital Therapeutic Device. This digital CBT-I approach aims to provide accessible, structured therapy sessions to manage insomnia without the side effects associated with medications.

What other types of research exist?

Promising novel alternatives to Prescription Digital Therapeutic Device (Cognitive Behavioral Therapy for Insomnia) for chronic insomnia patients in 2024 include: 1) New pharmacological treatments such as dual orexin receptor antagonists (e.g., lemborexant, daridorexant), which have shown efficacy in improving sleep onset and maintenance. 2) Advanced wearable sleep trackers and actigraphy devices that provide personalized sleep data and recommendations. 3) Non-pharmacological interventions like mindfulness-based cognitive therapy and intensive short-term dynamic psychotherapy, which have demonstrated effectiveness in treatment-resistant cases. 4) Light therapy and chronotherapy, which can help regulate circadian rhythms and improve sleep patterns.

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Behavioral Intervention

Digital Cognitive Behavioral Therapy for Chronic Insomnia (SLEEP-I Trial)

N/A

Waitlist Available

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 22-64 years

English-speaking (both reading and writing in English required)

Must not have

Those who have failed CBT for insomnia in the past

Those with untreated co-existing sleep conditions (e.g. sleep apnea)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 61 weeks post-randomization

Summary

This trial tests a mobile app that provides therapy to help people with chronic insomnia improve their sleep. The app teaches better sleep habits and uses Fitbit data to track progress. It aims to help those with long-term sleep problems.

Who is the study for?

This trial is for English-speaking adults aged 22-64 with chronic insomnia who can consent, use a smartphone with apps, and have primary care at YNHH or Mayo Clinic. It's not for pregnant individuals, shift workers with irregular sleep patterns, those without reliable internet and smartphone access, or people with certain psychiatric disorders or untreated sleep conditions.

What is being tested?

The study tests a mobile app delivering Cognitive Behavioral Therapy for Insomnia (CBT-I), linked to Fitbit data over 61 weeks. The aim is to see how well the app works in real-world settings when patients share their data through a new platform.

What are the potential side effects?

Since this intervention involves digital therapy using an app and Fitbit device rather than medication, typical drug side effects are not expected. However, users may experience discomfort from wearing the device or stress if technical issues arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 64 years old.

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I can read and write in English.

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I have been diagnosed with chronic insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tried cognitive behavioral therapy for insomnia without success.

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I have a sleep condition like sleep apnea that hasn't been treated.

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I have not been diagnosed with psychosis, schizophrenia, bipolar disorder, or any condition that makes sleep restriction unsafe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 61 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 61 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 61 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Anxiety

Change in Daytime Sleepiness

Depressive Symptoms

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PEAR-003b PDT InterventionExperimental Treatment3 Interventions

Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.

Group II: Control ArmPlacebo Group2 Interventions

Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PEAR-003b PDT Intervention

2021

N/A

~100

Fitbit

2021

N/A

~3560

Sleep education materials

2021

N/A

~100

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured program that helps individuals identify and replace thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. The mechanisms of action include stimulus control, sleep restriction, cognitive restructuring, and relaxation techniques. Stimulus control involves associating the bed with sleep only, while sleep restriction limits time in bed to increase sleep efficiency. Cognitive restructuring addresses negative thoughts about sleep, and relaxation techniques reduce pre-sleep anxiety. These interventions are crucial for chronic insomnia patients as they target the underlying psychological and behavioral factors contributing to insomnia, offering a long-term solution without the side effects associated with pharmacotherapy.