InsomniaSEDATIVENCT05027438

Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

A study testing Cognitive Behavioral Therapy for Insomnia and Deprescribing in people with Insomnia, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia
What is being tested?: Cognitive Behavioral Therapy for Insomnia and Deprescribing
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 22 Sep 2022to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

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

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 (e.g., Cognitive Behavioral Therapy for Insomnia [CBT-I]) 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.

Conditions: Insomnia
Being tested: Cognitive Behavioral Therapy for Insomnia, Deprescribing
Keywords: Insomnia, Veterans, Hypnotics and Sedatives, Deprescribing, Cognitive Behavioral Therapy for Insomnia, Telemedicine, Mobile Applications
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
DeprescribingBehavioural
Also called Gradual Dose Reduction, Tapering
The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes

Study groups in NCT05027438
Study group	Role	What they receive
COAST + Deprescribing	Experimental	CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Deprescribing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sedative-Hypnotic Medication Use Change
Change in dose % from baseline (T0; week 0) to post-treatment (T1; week 12)
Change in dose % from baseline (T0; week 0) to 3-month follow-up (T2; week 24)
Measured: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Secondary outcomes (6)

Sedative-Hypnotic Medication Cessation
Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24)
Measured: post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
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).
Measured: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
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).
Measured: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
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).
Measured: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Includes constructs of Physical Function, Participation in Social Roles, Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference and Intensity, and Cognitive Function. Constructs are scored individually (4 items, 4-20) except Cognitive Function (2 items, 2-10).
T-score: population mean=50 and a standard deviation=10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, Depression, Sleep, Pain, and Fatigue, 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, Cognitive Function, and Social Roles, 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).
Measured: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr)
The PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a preference score (PROMIS Preference, PROPr). Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Scores can be used in comparisons across groups and for cost-utility analyses. The profile includes all items in the PROMIS-29 Profile v2.1 plus two Cognitive Function Abilities items. T-scores from the measure can be used to calculate a preference-based score.
Measured: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 202230 Jun 2024

First posted30 Aug 2021
Study start22 Sep 2022
Primary completion31 Mar 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: pre-post design
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05027438
Sponsor's protocol ID: F3732-P
Other IDs: 1I21RX003732-01A1
Acronym: SEDATIVE
Status last verified: Mar 2025
First submitted: 20 Aug 2021
Last updated: 11 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bramoweth AD, Hough CE, McQuillan AD, Spitznogle BL, Thorpe CT, Lickel JJ, Boudreaux-Kelly M, Hamm ME, Germain A. Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial. JMIR Res Protoc. 2023 Jul 20;12:e47636. doi: 10.2196/47636.
PubMed 37471122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)
ClinicalTrials.gov ID: NCT05027438
Acronym / sponsor ID: SEDATIVE / F3732-P
Conditions: Insomnia
Keywords: Insomnia, Veterans, Hypnotics and Sedatives, Deprescribing, Cognitive Behavioral Therapy for Insomnia, Telemedicine, Mobile Applications
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 22 Sep 2022 (actual)
Primary completion: 31 Mar 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 30 Aug 2021 (actual)
Results: Posted 11 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: pre-post design

Arm	Type	Receives
COAST + Deprescribing	Experimental	Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: DeprescribingCBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Behavioral Therapy for InsomniaAlso: CBT-IA multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies	Behavioural	COAST + Deprescribing
DeprescribingAlso: Gradual Dose Reduction, TaperingThe reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes	Behavioural	COAST + Deprescribing

Primary outcome

Insomnia Severity Index (ISI) Change
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
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.
Sedative-Hypnotic Medication Use Change
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Change in dose % from baseline (T0; week 0) to post-treatment (T1; week 12) Change in dose % from baseline (T0; week 0) to 3-month follow-up (T2; week 24)

6 secondary outcomes

Sedative-Hypnotic Medication Cessation
Time frame: post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Sleep Onset Latency (SOL) Change
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Wake After Sleep Onset (WASO) Change
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Sleep Efficiency Change
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr)
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Results and safety

Results posted to the registry on 11 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COAST + Deprescribing	36	25

Primary outcome: Insomnia Severity Index (ISI) Change

Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24). Mean (Standard Deviation). Unit: score on a scale

Measure	COAST + Deprescribing n = 35
Baseline	14.63 (4.04)
Post-Treatment	6.13 (4.10)
3-month Follow-Up	7.17 (3.59)

COAST + Deprescribing: Mean Difference (Net): -7.58, p <0.001, Mixed Models Analysis
COAST + Deprescribing: Mean Difference (Net): -7.06, p <0.001, Mixed Models Analysis

Population analysed: intent to treat analysis - time frame sample size differs due to drop out

Primary outcome: Sedative-Hypnotic Medication Use Change

Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24). Mean (Standard Deviation). Unit: % medication dose relative to baseline

Measure	COAST + Deprescribing n = 22
baseline	100 (0)
post-treatment	41.45 (43.98)
3-month follow-up	37.74 (54.93)

COAST + Deprescribing: Mean Difference (Net): 58.55, p = 0.004, Friedman test
COAST + Deprescribing: Mean Difference (Net): 62.26, p = 0.005, Friedman test

Population analysed: intent to treat analysis - time frame sample size differs due to drop out

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 3-month follow-up assessment (1 year).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COAST + Deprescribing	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Limitations and caveats (from the sponsor): Drop out during intervention and failure to complete post-treatment and follow-up assessments resulted in smaller number of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37471122Bramoweth AD, Hough CE, McQuillan AD, Spitznogle BL, Thorpe CT, Lickel JJ, Boudreaux-Kelly M, Hamm ME, Germain A. Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial. JMIR Res Protoc. 2023 Jul 20;12:e47636. doi: 10.2196/47636.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam D. Bramoweth, PhD principal investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Insomnia and Deprescribing in people with Insomnia, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) Change (time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05027438, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.