Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

Insomnia Clinical Trial

— SEDATIVE  

Official title:

SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05027438
• Other study ID #: F3732-P
• Secondary ID: 1I21RX003732-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function.

Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform.

Aim 2: To assess Veteran acceptability and usability of the COAST platform.

Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• A disorder that would impair participation (e.g., cancer, uncontrolled pain, severe depression)

• A disorder that can be exacerbated by changes in sleep (e.g., seizure disorder, bipolar I disorder)

• High risk of suicide

• An active substance use disorder in past 6 months

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
• Deprescribing
The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI) Change	Total score (0-28): no insomnia (0-7); sub-threshold (8-14); moderate (15-21); and severe insomnia (22-28). A reduction pre- to post-treatment/follow-up of 8 points (or more) indicate a treatment response and a post-treatment/follow-up score or 7 (or less) indicate remission.	baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Primary	Sedative-Hypnotic Medication Use Change	T0, Baseline: medication name, dose, frequency of use (# nights/week); T1, Post-treatment: medication name, dose, frequency of use (# nights/week), >=50% reduction from baseline (yes/no); cessation (yes/no); T2, 3-month follow-up: medication name, dose, frequency of use (# nights/week), >=50% reduction from baseline (yes/no); cessation (yes/no)	baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Secondary	Sleep Diary - Sleep Onset Latency (SOL) Change	The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Sleep Onset Latency (SOL) is the subjective estimate of time it takes to fall asleep after going to bed and turning the lights out (or attempting to go to sleep). SOL is measured in minutes (lower values are better).	baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Secondary	Sleep Diary - Wake After Sleep Onset (WASO) Change	The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Wake After Sleep Onset (WASO) is the subjective estimate of time awake in the middle of the night, after falling asleep and before final rise time/out of bed. WASO is measured in minutes (lower values are better).	baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Secondary	Sleep Diary - Sleep Efficiency Change	The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Sleep Efficiency (SE) = (total sleep time [TST] / time in bed [TIB]) x 100. SE is measured as a percentage (range 0-100%; higher values are better).	baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Secondary	Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change	The PROMIS 29+2 includes measures of Physical Function, Social Roles, Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, Pain Intensity, and Cognitive Function. Each construct is scored individually (4 items, range 4-20) except Cognitive Function (2 items, range 2-10). A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.; When all constructs are scored together, a preference score is calculated, representing health-related quality of life ranging from 0 (as bad as dead) to 1 (perfect or ideal health).	baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)