Chronic InsomniaNCT05490550
Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)
A study testing COAST-enhanced CBTI and Military Treatment Facility Insomnia Care As Usual in people with Chronic Insomnia, run by Noctem, LLC at 1 site in United States.
Trial summary
The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- COAST-enhanced CBTI and Military Treatment Facility Insomnia Care As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Active duty service members, men and women, diagnosed with chronic insomnia and deemed eligible for CBTI by their treating clinician.
- Age 18 or older.
- Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do not compromise safety when completing study procedures.
- If using prescribed sleep medication(s), have received the medication(s) at a stable dosage for at least 4 weeks, with no scheduled change in medication or dosage over the acute intervention phase (up to 12 weeks)
- Owning or ability to use a smartphone (iPhone or Android) that is no older than 5 years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operating system)
Who cannot join
- Presence of an untreated or under-treated comorbid sleep disorder that requires independent treatment or that may be exacerbated by sleep restriction or stimuli control, e.g., obstructive sleep apnea (OSA) or rapid-eye-movement (REM) behavior disorder or sleep walking with a history of injury to self or others.
- Acute psychiatric distress associated with marked impairments in functioning or that limits engagement in CBTI, adversely impacts the risk/benefit ratio of participating in the study, or requires immediate attention, as indicated by, but not limited to, the examples listed below. Please note that each referring clinician will determine whether a patient is eligible for the study.
- Having planned or attempted suicide or the harming of others in the past 6 months.
- Seeking and/or receiving treatment at psychiatric clinic facility at a level that requires inpatient or partial hospitalization level of psychiatric care.
- Currently requiring the support of an assigned case manager for services such as coordination of medications, appointments, transportation, and/or for completing activities of daily living.
- Active substance use disorder.
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- Past or current psychotic or bipolar disorder or sub-threshold symptoms of psychotic or bipolar disorders.
- Currently pregnant, breastfeeding, or being the parent of a newborn < 3 months old.
- Untreated seizure disorder.
- Suspected, diagnosed, or inadequately treated sleep apnea (less than 4 hours of CPAP use per night).
- Anticipates relocating/moving out of state in the next 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Madigan Army Medical Center
Lakewood, Washington, 98431
Brian O'Reilly
About this study
Official title: Comparing Insomnia Care As Usual to Digital Augmentation
The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.
Read the detailed description
Chronic insomnia is pervasive among service members and adversely affects health and readiness. Insomnia rarely remits spontaneously, and sleep-focused treatments are required to reduce or eliminate insomnia. Cognitive Behavioral Treatment of Insomnia (CBTI) is the first line treatment for insomnia. CBTI remains underutilized and is often unavailable in care settings where service members receive sleep healthcare. Digital health technology is one of the strategic components identified by the DHA to support behavioral health, including sleep health. NOCTEM® has developed and validated its Clinician Operated Assistive Sleep Technology (COAST™) platform to scale delivery and access to CBTI. This non-inferiority trial will evaluate and compare the changes in insomnia severity following COAST-enhanced CBTI or insomnia care as usual (ICAU) pre- to post-treatment and at the 3-month follow up. Secondary outcomes of interest include changes in depression and anxiety over time, and patient satisfaction with insomnia care following COAST-enhanced CBTI or ICAU.
- Conditions
- Chronic Insomnia
- Being tested
- COAST-enhanced CBTI, Military Treatment Facility Insomnia Care As Usual
- Keywords
- Insomnia, Cognitive Behavioral Therapy for Insomnia (CBTI), Digital Technology, Adherence Monitoring
- 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.
COAST-enhanced CBTIBehavioural
Participants will receive CBTI delivered through the COAST platform by one of NOCTEM's certified and licensed COAST clinician. Communication between the participant and licensed clinician will occur primarily through COAST's HIPAA-compliant text messaging, but clinicians and patients may elect to connect via telephone calls or HIPAA-compliant secure videoconference if needed.
Military Treatment Facility Insomnia Care As UsualBehavioural
Participants will receive the insomnia care offered at their site following current delivery practices (i.e., face-to-face or virtual; individual or group format). During the treatment phase, participants randomized to ICAU will be instructed to communicate with their clinicians as needed, according to standard procedures in place.
| Study group | Role | What they receive |
|---|---|---|
| COAST-enhanced CBTI | Active comparator | Patients randomized to COAST will receive CBTI via the COAST platform, with the assistance of a licensed clinician via NOCTEM's digital sleep hub. Participants will utilize the COAST patient app on their smartphone for engagement in insomnia treatment and receipt of clinician's recommendations. COAST clinicians will utilize the COAST web-based portal for adherence monitoring, progress review, and for providing personalized insomnia treatment recommendations. Receives: Behavioral: COAST-enhanced CBTI |
| Military Treatment Facility Insomnia Care As Usual | Active comparator | Patients randomized to the ICAU arm will receive insomnia care as usual by a certified clinician at their respective site, according to current referral and treatment practices. Receives: Behavioral: Military Treatment Facility Insomnia Care As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity
Insomnia Severity Index (ISI)
Measured: baseline
Insomnia Severity
Insomnia Severity Index (ISI)
Measured: 6-8 week check-in
Insomnia Severity
Insomnia Severity Index (ISI)
Measured: 3-month follow up
Symptoms of Depression
Patient Health Questionnaire-2 (PHQ-2)
Measured: baseline
Symptoms of Depression
Patient Health Questionnaire-2 (PHQ-2)
Measured: 6-8 week check-in
Symptoms of Depression
Patient Health Questionnaire-2 (PHQ-2)
Measured: 3-month follow up
Symptoms of Anxiety
Generalized Anxiety Disorder 2-item (GAD-2)
Measured: baseline
Symptoms of Anxiety
Generalized Anxiety Disorder 2-item (GAD-2)
Measured: 6-8 week check-in
Symptoms of Anxiety
Generalized Anxiety Disorder 2-item (GAD-2)
Measured: 3-month follow up
Acceptability of Insomnia Care
An adapted version of the Insomnia Treatment Acceptability Scale (ITAS) with ratings of perceived acceptability and treatment preference for both COAST-enhanced CBTI and insomnia care as usual (ICAU).
Measured: 6-8 week check-in
Satisfaction with Insomnia Care
Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.
Measured: 6-8 week check in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start16 Aug 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two study arms (COAST-enhanced CBTI or insomnia care as usual) at the site level.
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noctem, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Anne Germain, Noctem, LLC
- Investigators
- Anne Germain, Principal investigator, Noctem, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490550
- Sponsor's protocol ID
- JW210372
- Status last verified
- Mar 2024
- First submitted
- 30 Jul 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986.
PubMed 33164742Pulantara IW, Parmanto B, Germain A. Clinical Feasibility of a Just-in-Time Adaptive Intervention App (iREST) as a Behavioral Sleep Treatment in a Military Population: Feasibility Comparative Effectiveness Study. J Med Internet Res. 2018 Dec 7;20(12):e10124. doi: 10.2196/10124.
PubMed 30530452Germain A, Wolfson M, Brock MS, O'Reilly B, Hearn H, Knowles S, Mysliwiec V, Wallace ML. Digital CBTI hubs as a treatment augmentation strategy in military clinics: study protocol for a pragmatic randomized clinical trial. Trials. 2023 Oct 6;24(1):648. doi: 10.1186/s13063-023-07686-2.
PubMed 37803393
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Insomnia Care As Usual to Digital Augmentation
- ClinicalTrials.gov ID
- NCT05490550
- Acronym / sponsor ID
- JW210372
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia, Cognitive Behavioral Therapy for Insomnia (CBTI), Digital Technology, Adherence Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Noctem, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.
Detailed description
Chronic insomnia is pervasive among service members and adversely affects health and readiness. Insomnia rarely remits spontaneously, and sleep-focused treatments are required to reduce or eliminate insomnia. Cognitive Behavioral Treatment of Insomnia (CBTI) is the first line treatment for insomnia. CBTI remains underutilized and is often unavailable in care settings where service members receive sleep healthcare. Digital health technology is one of the strategic components identified by the DHA to support behavioral health, including sleep health. NOCTEM® has developed and validated its Clinician Operated Assistive Sleep Technology (COAST™) platform to scale delivery and access to CBTI. This non-inferiority trial will evaluate and compare the changes in insomnia severity following COAST-enhanced CBTI or insomnia care as usual (ICAU) pre- to post-treatment and at the 3-month follow up. Secondary outcomes of interest include changes in depression and anxiety over time, and patient satisfaction with insomnia care following COAST-enhanced CBTI or ICAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two study arms (COAST-enhanced CBTI or insomnia care as usual) at the site level.
| Arm | Type | Receives |
|---|---|---|
| COAST-enhanced CBTI | Active comparator | Behavioral: COAST-enhanced CBTIPatients randomized to COAST will receive CBTI via the COAST platform, with the assistance of a licensed clinician via NOCTEM's digital sleep hub. Participants will utilize the COAST patient app on their smartphone for engagement in insomnia treatment and receipt of clinician's recommendations. COAST clinicians will utilize the COAST web-based portal for adherence monitoring, progress review, and for providing personalized insomnia treatment recommendations. |
| Military Treatment Facility Insomnia Care As Usual | Active comparator | Behavioral: Military Treatment Facility Insomnia Care As UsualPatients randomized to the ICAU arm will receive insomnia care as usual by a certified clinician at their respective site, according to current referral and treatment practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active duty service members, men and women, diagnosed with chronic insomnia and deemed eligible for CBTI by their treating clinician.
- Age 18 or older.
- Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do not compromise safety when completing study procedures.
- If using prescribed sleep medication(s), have received the medication(s) at a stable dosage for at least 4 weeks, with no scheduled change in medication or dosage over the acute intervention phase (up to 12 weeks)
- Owning or ability to use a smartphone (iPhone or Android) that is no older than 5 years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operating system)
Key exclusion criteria (11 listed)
- Presence of an untreated or under-treated comorbid sleep disorder that requires independent treatment or that may be exacerbated by sleep restriction or stimuli control, e.g., obstructive sleep apnea (OSA) or rapid-eye-movement (REM) behavior disorder or sleep walking with a history of injury to self or others.
- Acute psychiatric distress associated with marked impairments in functioning or that limits engagement in CBTI, adversely impacts the risk/benefit ratio of participating in the study, or requires immediate attention, as indicated by, but not limited to, the examples listed below. Please note that each referring clinician will determine whether a patient is eligible for the study.
- Having planned or attempted suicide or the harming of others in the past 6 months.
- Seeking and/or receiving treatment at psychiatric clinic facility at a level that requires inpatient or partial hospitalization level of psychiatric care.
- Currently requiring the support of an assigned case manager for services such as coordination of medications, appointments, transportation, and/or for completing activities of daily living.
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 |
|---|---|---|
| COAST-enhanced CBTIParticipants will receive CBTI delivered through the COAST platform by one of NOCTEM's certified and licensed COAST clinician. Communication between the participant and licensed clinician will occur primarily through COAST's HIPAA-compliant text messaging, but clinicians and patients may elect to connect via telephone calls or HIPAA-compliant secure videoconference if needed. | Behavioural | COAST-enhanced CBTI |
| Military Treatment Facility Insomnia Care As UsualParticipants will receive the insomnia care offered at their site following current delivery practices (i.e., face-to-face or virtual; individual or group format). During the treatment phase, participants randomized to ICAU will be instructed to communicate with their clinicians as needed, according to standard procedures in place. | Behavioural | Military Treatment Facility Insomnia Care As Usual |
Primary outcome
Insomnia Severity
Time frame: baseline
Insomnia Severity Index (ISI)
Insomnia Severity
Time frame: 6-8 week check-in
Insomnia Severity Index (ISI)
Insomnia Severity
Time frame: 3-month follow up
Insomnia Severity Index (ISI)
Symptoms of Depression
Time frame: baseline
Patient Health Questionnaire-2 (PHQ-2)
Symptoms of Depression
Time frame: 6-8 week check-in
Patient Health Questionnaire-2 (PHQ-2)
Symptoms of Depression
Time frame: 3-month follow up
Patient Health Questionnaire-2 (PHQ-2)
Symptoms of Anxiety
Time frame: baseline
Generalized Anxiety Disorder 2-item (GAD-2)
Symptoms of Anxiety
Time frame: 6-8 week check-in
Generalized Anxiety Disorder 2-item (GAD-2)
Symptoms of Anxiety
Time frame: 3-month follow up
Generalized Anxiety Disorder 2-item (GAD-2)
Acceptability of Insomnia Care
Time frame: 6-8 week check-in
An adapted version of the Insomnia Treatment Acceptability Scale (ITAS) with ratings of perceived acceptability and treatment preference for both COAST-enhanced CBTI and insomnia care as usual (ICAU).
Satisfaction with Insomnia Care
Time frame: 6-8 week check in
Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 33164742Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986.
- Background: PubMed 30530452Pulantara IW, Parmanto B, Germain A. Clinical Feasibility of a Just-in-Time Adaptive Intervention App (iREST) as a Behavioral Sleep Treatment in a Military Population: Feasibility Comparative Effectiveness Study. J Med Internet Res. 2018 Dec 7;20(12):e10124. doi: 10.2196/10124.
- Derived from this study: PubMed 37803393Germain A, Wolfson M, Brock MS, O'Reilly B, Hearn H, Knowles S, Mysliwiec V, Wallace ML. Digital CBTI hubs as a treatment augmentation strategy in military clinics: study protocol for a pragmatic randomized clinical trial. Trials. 2023 Oct 6;24(1):648. doi: 10.1186/s13063-023-07686-2.
- 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.
Anne Germain principal investigator
Noctem, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COAST-enhanced CBTI and Military Treatment Facility Insomnia Care As Usual in people with Chronic Insomnia, run by Noctem, LLC 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Germain, PhD ((412) 897-3183, anne@noctemhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity (time frame: baseline). The study lists 11 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 NCT05490550, which also lists 3 linked publications.
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 21 Mar 2024.