Alcohol Abuse With Alcohol-Induced Sleep DisorderNCT06108115
Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder
A study testing CueToSleep (Full Intervention Package) in people with Alcohol Abuse With Alcohol-Induced Sleep Disorder and Alcohol Use Disorder (AUD), run by HealthRhythms, Inc. at 1 site in United States.
Trial summary
In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score >4) and are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse With Alcohol-Induced Sleep Disorder, Alcohol Use Disorder (AUD), Sleep Disorder
- What is being tested?
- CueToSleep (Full Intervention Package)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 23 Aug 2023
- 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
- Age 18 and older
- Meets criteria for lifetime alcohol use disorder (AUD), as defined by DSM-5
- Score >/= 4 on AUDIT-C
- Reports difficulties with sleep and scores >/= 10 on the Insomnia Severity Index
- Has been in recovery (abstinent) for >/= 2 weeks, but less than 6 months
- Ability and willingness to provide informed consent
- Ability to understand and comprehend consent and protocol documents in English.
- Uses a smartphone compatible with the app.
Who cannot join
- Psychotic mental disorder other than bipolar disorder
- Current diagnosis of OCD, anorexia/ bulimia eating disorder, or antisocial personality disorder
- Acute suicidal ideation with plan or intent
- Meet DSM-5 criteria for current moderate to severe substance use disorder (SUD)
- Unable to comply with study procedures or protocols
Trial locations and contacts
1 site in 1 country.
About this study
In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score >4) and are experiencing sleep problems (ISI score >/= 10). 64 of these individuals will be randomly allocated to receive the full HealthRhythms package (sensing, trending, and stabilization) on their smartphones, while 64 will be asked to consent to sensing only. The duration of the study will be 14 weeks.
The primary outcome measures of the RCT will be the ISI (Insomnia Severity Index). The investigators hypothesize that those receiving the full package will demonstrate lower levels of sleep disturbance.
Read the detailed description
We will conduct a 14-week randomized controlled trial (RCT) of CueToSleep (behavioral monitoring via smartphone sensors and phone-based Cognitive Behavior Therapy for Insomnia) versus Measure (smartphone-based monitoring only). The sample will be 128 individuals with alcohol use disorder who have been abstinent for at least two weeks and are experiencing sleep difficulties. Using a block randomization scheme, these individuals will be randomly allocated on a 1:1 basis to the experimental condition (CueToSleep) or to the control condition (Measure). The components of the CueToSleep intervention include: 1) education about sleep and its regulation and sleep hygiene; 2) alcohol withdrawal-specific psychoeducation 3) personalized and context-specific suggestions for behavior change to address sleep problems using data obtained from the monitoring portion of CueToSleep; 4) feedback to the user on his/her progress; 5) feedback from the user about the usefulness of the suggestions; 6) adjustment of recommendations based on progress, adherence and feedback from the user.
The primary outcome is change in sleep difficulties as measured by the Insomnia Severity Index (ISI). The study is powered to detect at least medium Cohen's d effect size for this primary outcome. The secondary outcome of interest is proportion relapsing to heavy drinking (≥4 drinks in a day for women; ≥5 drinks in a day for men). Number of drinks consumed on the previous day will be queried daily via smartphone and relapse to heavy drinking will be determined from these participant self-reports.
For our primary outcome, we will fit a 2-level linear mixed effects model with a random intercept and slope to test for group (experimental vs. control) differences in the slope of ISI scores over 14 weeks. This model will regress repeatedly measured ISI score on week, group, the week by group interaction, and covariates (age, sex, living status, employment status). Secondarily, to allow further flexibility in the trajectory of ISI scores over the course of the study, we will fit a mixed effects model with categorical time, and specific contrasts to test changes from baseline to 14 weeks.
For our secondary outcome, we will fit a cox proportional hazards model to regress time to relapse on group and covariates (age, sex, living status, employment status). This model accounts for participants who are censored due to early dropout from the study. Secondarily, we will use simple non-parametric statistics to compare the proportion relapsing to heavy drinking in each group.
All analyses will use an intent-to-treat (ITT) strategy where all participants are included regardless of adherence to the randomized condition.
- Conditions
- Alcohol Abuse With Alcohol-Induced Sleep Disorder, Alcohol Use Disorder (AUD), Sleep Disorder, Sleep Disturbance
- Being tested
- CueToSleep (Full Intervention Package)
- Medical subject headings
- Alcoholism, Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CueToSleep (Full Intervention Package)Behavioural
Individuals will be randomly allocated to receive the full Health Rhythms package (CueToSleep) program on their smartphones. The package includes 24/7 behavioral sensing from the participant's smartphone using the global positioning system, accelerometer, and screen on/off state, as well as a series of psychoeducational learning screens about the relationship among alcohol, mood disturbance and sleep, and personalized suggestions for behavior change to improve sleep that will be sent to the participant every 3 to 4 days. These suggestions will be based on behaviors indicated by the individual participant's sensor data over the previous 3 to 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: CueToSleep (Full Intervention Package) | Experimental | Individuals will be randomly allocated to receive the full Health Rhythms package (CueToSleep) program on their smartphones. The package includes 24/7 behavioral sensing from the participant's smartphone using the global positioning system, accelerometer, and screen on/off state, as well as a series of psychoeducational learning screens about the relationship among alcohol, mood disturbance and sleep, and personalized suggestions for behavior change to improve sleep that will be sent to the participant every 3 to 4 days. These suggestions will be based on behaviors indicated by the individual participant's sensor data over the previous 3 to 4 days. Receives: Behavioral: CueToSleep (Full Intervention Package) |
| Measure (Behavioral Sensing Only) | No intervention | Individuals will only be monitored using the passive sensing capabilities of the Full Intervention Package on their smartphones. These participants will not receive psychoeducational learning screens or behavior change suggestions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The Insomnia Severity Index are self-reported perceptions of sleep
Measured: Change from Baseline at 3, 6,10 and 14 weeks
Secondary outcomes (1)
Relapse to Heavy Drinking
Patient self report
Measured: Daily over the course of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start6 Oct 2021
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse With Alcohol-Induced Sleep DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthRhythms, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ellen Frank, PhD, Principal investigator, Health Rhythms
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108115
- Sponsor's protocol ID
- 0799011810000
- Status last verified
- Jun 2024
- First submitted
- 27 Sep 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06108115
- Acronym / sponsor ID
- 0799011810000
- Conditions
- Alcohol Abuse With Alcohol-Induced Sleep Disorder, Alcohol Use Disorder (AUD), Sleep Disorder, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- HealthRhythms, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 30 Oct 2023 (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.
In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score >4) and are experiencing sleep problems (ISI score >/= 10). 64 of these individuals will be randomly allocated to receive the full HealthRhythms package (sensing, trending, and stabilization) on their smartphones, while 64 will be asked to consent to sensing only. The duration of the study will be 14 weeks.
The primary outcome measures of the RCT will be the ISI (Insomnia Severity Index). The investigators hypothesize that those receiving the full package will demonstrate lower levels of sleep disturbance.
Detailed description
We will conduct a 14-week randomized controlled trial (RCT) of CueToSleep (behavioral monitoring via smartphone sensors and phone-based Cognitive Behavior Therapy for Insomnia) versus Measure (smartphone-based monitoring only). The sample will be 128 individuals with alcohol use disorder who have been abstinent for at least two weeks and are experiencing sleep difficulties. Using a block randomization scheme, these individuals will be randomly allocated on a 1:1 basis to the experimental condition (CueToSleep) or to the control condition (Measure). The components of the CueToSleep intervention include: 1) education about sleep and its regulation and sleep hygiene; 2) alcohol withdrawal-specific psychoeducation 3) personalized and context-specific suggestions for behavior change to address sleep problems using data obtained from the monitoring portion of CueToSleep; 4) feedback to the user on his/her progress; 5) feedback from the user about the usefulness of the suggestions; 6) adjustment of recommendations based on progress, adherence and feedback from the user.
The primary outcome is change in sleep difficulties as measured by the Insomnia Severity Index (ISI). The study is powered to detect at least medium Cohen's d effect size for this primary outcome. The secondary outcome of interest is proportion relapsing to heavy drinking (≥4 drinks in a day for women; ≥5 drinks in a day for men). Number of drinks consumed on the previous day will be queried daily via smartphone and relapse to heavy drinking will be determined from these participant self-reports.
For our primary outcome, we will fit a 2-level linear mixed effects model with a random intercept and slope to test for group (experimental vs. control) differences in the slope of ISI scores over 14 weeks. This model will regress repeatedly measured ISI score on week, group, the week by group interaction, and covariates (age, sex, living status, employment status). Secondarily, to allow further flexibility in the trajectory of ISI scores over the course of the study, we will fit a mixed effects model with categorical time, and specific contrasts to test changes from baseline to 14 weeks.
For our secondary outcome, we will fit a cox proportional hazards model to regress time to relapse on group and covariates (age, sex, living status, employment status). This model accounts for participants who are censored due to early dropout from the study. Secondarily, we will use simple non-parametric statistics to compare the proportion relapsing to heavy drinking in each group.
All analyses will use an intent-to-treat (ITT) strategy where all participants are included regardless of adherence to the randomized condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: CueToSleep (Full Intervention Package) | Experimental | Behavioral: CueToSleep (Full Intervention Package)Individuals will be randomly allocated to receive the full Health Rhythms package (CueToSleep) program on their smartphones. The package includes 24/7 behavioral sensing from the participant's smartphone using the global positioning system, accelerometer, and screen on/off state, as well as a series of psychoeducational learning screens about the relationship among alcohol, mood disturbance and sleep, and personalized suggestions for behavior change to improve sleep that will be sent to the participant every 3 to 4 days. These suggestions will be based on behaviors indicated by the individual participant's sensor data over the previous 3 to 4 days. |
| Measure (Behavioral Sensing Only) | No intervention | –Individuals will only be monitored using the passive sensing capabilities of the Full Intervention Package on their smartphones. These participants will not receive psychoeducational learning screens or behavior change suggestions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 and older
- Meets criteria for lifetime alcohol use disorder (AUD), as defined by DSM-5
- Score >/= 4 on AUDIT-C
- Reports difficulties with sleep and scores >/= 10 on the Insomnia Severity Index
- Has been in recovery (abstinent) for >/= 2 weeks, but less than 6 months
Key exclusion criteria (5 listed)
- Psychotic mental disorder other than bipolar disorder
- Current diagnosis of OCD, anorexia/ bulimia eating disorder, or antisocial personality disorder
- Acute suicidal ideation with plan or intent
- Meet DSM-5 criteria for current moderate to severe substance use disorder (SUD)
- Unable to comply with study procedures or protocols
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 |
|---|---|---|
| CueToSleep (Full Intervention Package)Individuals will be randomly allocated to receive the full Health Rhythms package (CueToSleep) program on their smartphones. The package includes 24/7 behavioral sensing from the participant's smartphone using the global positioning system, accelerometer, and screen on/off state, as well as a series of psychoeducational learning screens about the relationship among alcohol, mood disturbance and sleep, and personalized suggestions for behavior change to improve sleep that will be sent to the participant every 3 to 4 days. These suggestions will be based on behaviors indicated by the individual participant's sensor data over the previous 3 to 4 days. | Behavioural | Behavioral: CueToSleep (Full Intervention Package) |
Primary outcome
Insomnia Severity Index
Time frame: Change from Baseline at 3, 6,10 and 14 weeks
The Insomnia Severity Index are self-reported perceptions of sleep
1 secondary outcome
Relapse to Heavy Drinking
Time frame: Daily over the course of 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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.
Ellen Frank, PhD principal investigator
Health Rhythms
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CueToSleep (Full Intervention Package) in people with Alcohol Abuse With Alcohol-Induced Sleep Disorder and Alcohol Use Disorder (AUD), run by HealthRhythms, Inc. 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 8 inclusion and 5 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 1 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Change from Baseline at 3, 6,10 and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.