N/A
N=100
Prescription Digital Therapeutic for the Treatment of Insomnia
Insomnia Chronic
Bottom Line
View on ClinicalTrials.gov: NCT04909229 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change in Insomnia Severity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEAR-003b PDT Intervention (Device); Fitbit (Device); Sleep education materials (Behavioral)
- Age
- Adult · 22+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insomnia Severity |
— | — |
| SECONDARY Change in Insomnia Severity |
— | — |
| SECONDARY Change in Insomnia Severity |
— | — |
| SECONDARY Change in Insomnia Severity |
— | — |
| SECONDARY Change in Depressive Symptoms |
-2.0; 0.0 | — |
| SECONDARY Change in Depressive Symptoms |
-2.0; 0.0 | — |
| SECONDARY Change in Depressive Symptoms |
-2.0; 0.0 | — |
| SECONDARY Change in Depressive Symptoms |
-2.0; 0.0 | — |
| SECONDARY Change in Anxiety |
-2.0; -1.0 | — |
| SECONDARY Change in Anxiety |
-2.0; -1.0 | — |
| SECONDARY Change in Anxiety |
-2.0; -1.0 | — |
| SECONDARY Change in Anxiety |
-2.0; -1.0 | — |
| SECONDARY Change in Stress |
0.0; -1.0 | — |
| SECONDARY Change in Stress |
0.0; -1.0 | — |
| SECONDARY Change in Stress |
0.0; -1.0 | — |
| SECONDARY Change in Stress |
0.0; -1.0 | — |
| SECONDARY Change in Quality of Life (PCS) |
-1.0; -4.1 | — |
| SECONDARY Change in Quality of Life (PCS) |
-1.0; -4.1 | — |
| SECONDARY Change in Quality of Life (PCS) |
-1.0; -4.1 | — |
| SECONDARY Change in Quality of Life (PCS) |
-1.0; -4.1 | — |
| SECONDARY Change in Daytime Sleepiness |
-1.0; 0.0 | — |
| SECONDARY Change in Daytime Sleepiness |
-1.0; 0.0 | — |
| SECONDARY Change in Daytime Sleepiness |
-1.0; 0.0 | — |
| SECONDARY Change in Daytime Sleepiness |
-1.0; 0.0 | — |
| SECONDARY Healthcare Utilization |
— | — |
| SECONDARY Healthcare Utilization |
— | — |
| SECONDARY Healthcare Utilization |
— | — |
| SECONDARY Healthcare Utilization |
— | — |
| SECONDARY Medication Utilization |
— | — |
| SECONDARY Medication Utilization |
— | — |
| SECONDARY Medication Utilization |
— | — |
| SECONDARY Medication Utilization |
— | — |
| SECONDARY Change in Sleep Efficiency |
11.6; 15.8 | — |
| SECONDARY Change in Sleep Efficiency |
11.6; 15.8 | — |
| SECONDARY Change in Sleep Efficiency |
11.6; 15.8 | — |
| SECONDARY Change in Sleep Efficiency |
11.6; 15.8 | — |
| SECONDARY Change in Sleep Onset Latency |
-0.955; 0.184 | — |
| SECONDARY Change in Sleep Onset Latency |
-0.955; 0.184 | — |
| SECONDARY Change in Sleep Onset Latency |
-0.955; 0.184 | — |
| SECONDARY Change in Sleep Onset Latency |
-0.955; 0.184 | — |
| SECONDARY Change in Health Utility Score |
3.7; 0.5 | — |
| SECONDARY Change in Health Utility Score |
3.7; 0.5 | — |
| SECONDARY Change in Health Utility Score |
3.7; 0.5 | — |
| SECONDARY Change in Health Utility Score |
3.7; 0.5 | — |
| SECONDARY Change in Quality of Life (MCS) |
1.9; 2.2 | — |
| SECONDARY Change in Quality of Life (MCS) |
1.9; 2.2 | — |
| SECONDARY Change in Quality of Life (MCS) |
1.9; 2.2 | — |
| SECONDARY Change in Quality of Life (MCS) |
1.9; 2.2 | — |
Summary
This will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia using a novel patient-centered data-sharing platform with linkage to Fitbit for 61 weeks
Eligibility Criteria
Inclusion Criteria
- • Age between 22-64 years
- English-speaking (both reading and writing in English required)
- Diagnosis of chronic insomnia
- Participant is willing and able to give consent and participate in study
- Participant has an email account or is willing to create one and a smartphone able to download the necessary applications
- Participant is willing and able to use the PDT, the Hugo data sharing platform and the syncable devices (e.g. Fitbit)
- Participant has primary care at YNHH or Mayo Clinic
Exclusion Criteria
- Pregnancy
- Shift work or family/other commitments that interfere with establishment of regular night-time sleep patterns, and if wake/sleep time is outside the ranges of 4:00h - 10:00h (wake time) and 20:00h - 02:00h (bed time)
- Absence of a reliable internet access and smartphone
- A reported diagnosis of psychosis, schizophrenia or bipolar disorder, or any medical disorders contraindicated with sleep restriction
- Current involvement in a non-medication treatment program for insomnia (participants are still eligible if they are taking traditional sleep medications)
- Those with untreated co-existing sleep conditions (e.g. sleep apnea)
- Those who have failed CBT for insomnia in the past
Data sourced from ClinicalTrials.gov (NCT04909229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.