Chronic InsomniaRESETNCT07156383
Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study
A study testing Cognitive Behavioral Therapy for Insomnia in people with Chronic Insomnia, run by University of Notre Dame at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stress response system. 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?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18-years-old
- Speaks English
- Meets DSM-5 criteria for Insomnia Disorder, determined through initial screener than verified during brief clinical interview (at intake)
Who cannot join
- Sleep disorders other than Insomnia
- Endocrine disorders
- Extreme sleep schedule (i.e. shift workers)
- Currently taking sleep medication
- Currently taking medication for endocrine dysfunction
- Currently taking medication that interferes with sleep or cortisol levels
Show all 11Show fewer
- Excessive alcohol/substance use or AUD/SUD
- Serious mental illness
- Chronic medical conditions (which may be exacerbated by sleep restriction)
- Pregnant or nursing women
- Women in the peri-menopausal stage due to irregular menses and fluctuations in sex hormones.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Notre Dame
Notre Dame, Indiana, 46556
Ivan Vargas, 574-631-5914, ivargas@nd.edu
Emma Janes, ejanes@nd.edu
About this study
Official title: Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia
The purpose of this study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stress response system. The primary research aims are: 1) To determine whether changes in cortisol functioning are related to improvements in sleep consolidation (4-week CBT-I), sleep duration (10-week CBT-I) or both, AND 2) to examine whether these improvements are more pronounced among individuals with insomnia and short sleep duration (compared to insomnia with 'normal' sleep duration).This study will recruit individuals with chronic insomnia: half with reported short sleep duration (less than 6 hours of sleep on an average night) and half with reported non-short sleep duration (6 or more hours per night). Participants will complete an in-lab assessment on four different occasions. During the first visit, they will confirm eligibility, complete an online survey, complete an in-lab stress task (with saliva samples), and provide a hair sample to measure cortisol (a hormone). They will then be sent home with a home sleep test as a final eligibility check (to rule out sleep disorders other than insomnia), an actigraphy watch to measure their sleep, and collection tubes to provide saliva samples to measure cortisol. We will then track the participants' sleep using online daily diaries and actigraphy for four week. Following the 4-week baseline period, participants will come in for a second in-lab visit (same procedures as the first visit) and then be randomized to receive either four or ten weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a empirically supported behavioral treatment for insomnia and the first-line treatment for chronic insomnia. Sleep patterns and insomnia symptoms will continue to be monitored via diaries during the intervention phase. The third visit will take place once the participant has completed the intervention and the fourth visit will occur three months following the third visit (3 months post-treatment). The 3rd and 4th visits will again replicate the same procedures conducted during the initial lab visit.
- Conditions
- Chronic Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Sleep Initiation and Maintenance Disorders, Insomnia Disorder, Sleep Disorders, Cortisol, Sleep Deprivation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first line treatment for Insomnia. Participants will receive weekly CBT-I during which they will receive the tools to improve their sleep.
| Study group | Role | What they receive |
|---|---|---|
| 4-Week CBT-I | Experimental | Participants in this arm will receive 4 weeks of CBT-I. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| 10-Week CBT-I | Experimental | Participants in this arm will receive 10 weeks of CBT-I. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Symptoms
Total score on the Insomnia Severity Index (ISI), which ranges from 0-28. Higher scores indicate greater insomnia severity, while lower scores indicate less insomnia severity.
Measured: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
Sleep Continuity Disturbance
Mean sleep latency, wake after sleep onset, and early morning awakenings (in minutes assessed via daily sleep diaries).
Measured: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
Total Sleep Time
Mean sleep duration (in minutes) assessed via daily sleep diaries
Measured: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
HPA-Axis Functioning
Salivary cortisol assessed in three ways: hair (chronic stressor exposure), at-home saliva (basal cortisol), and saliva in response to an in-lab stressor (stress reactivity).
Measured: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start29 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- A within, between subjects design will be used with a four week run-in period (to establish a baseline) prior to the intervention phase (randomly assigned to one of two active interventions that are administered in parallel).
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Vargas, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156383
- Sponsor's protocol ID
- 25-01-9063
- Acronym
- RESET
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available upon completion of the study and publication of the study results. These data will be made available online through a dedicated study site.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT07156383
- Acronym / sponsor ID
- RESET / 25-01-9063
- Conditions
- Chronic Insomnia
- Keywords
- Sleep Initiation and Maintenance Disorders, Insomnia Disorder, Sleep Disorders, Cortisol, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Sep 2025 (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 study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stress response system. The primary research aims are: 1) To determine whether changes in cortisol functioning are related to improvements in sleep consolidation (4-week CBT-I), sleep duration (10-week CBT-I) or both, AND 2) to examine whether these improvements are more pronounced among individuals with insomnia and short sleep duration (compared to insomnia with 'normal' sleep duration).This study will recruit individuals with chronic insomnia: half with reported short sleep duration (less than 6 hours of sleep on an average night) and half with reported non-short sleep duration (6 or more hours per night). Participants will complete an in-lab assessment on four different occasions. During the first visit, they will confirm eligibility, complete an online survey, complete an in-lab stress task (with saliva samples), and provide a hair sample to measure cortisol (a hormone). They will then be sent home with a home sleep test as a final eligibility check (to rule out sleep disorders other than insomnia), an actigraphy watch to measure their sleep, and collection tubes to provide saliva samples to measure cortisol. We will then track the participants' sleep using online daily diaries and actigraphy for four week. Following the 4-week baseline period, participants will come in for a second in-lab visit (same procedures as the first visit) and then be randomized to receive either four or ten weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a empirically supported behavioral treatment for insomnia and the first-line treatment for chronic insomnia. Sleep patterns and insomnia symptoms will continue to be monitored via diaries during the intervention phase. The third visit will take place once the participant has completed the intervention and the fourth visit will occur three months following the third visit (3 months post-treatment). The 3rd and 4th visits will again replicate the same procedures conducted during the initial lab visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A within, between subjects design will be used with a four week run-in period (to establish a baseline) prior to the intervention phase (randomly assigned to one of two active interventions that are administered in parallel).
| Arm | Type | Receives |
|---|---|---|
| 4-Week CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaParticipants in this arm will receive 4 weeks of CBT-I. |
| 10-Week CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaParticipants in this arm will receive 10 weeks of CBT-I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18-years-old
- Speaks English
- Meets DSM-5 criteria for Insomnia Disorder, determined through initial screener than verified during brief clinical interview (at intake)
Key exclusion criteria (11 listed)
- Sleep disorders other than Insomnia
- Endocrine disorders
- Extreme sleep schedule (i.e. shift workers)
- Currently taking sleep medication
- Currently taking medication for endocrine dysfunction
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 InsomniaCognitive Behavioral Therapy for Insomnia (CBT-I) is the first line treatment for Insomnia. Participants will receive weekly CBT-I during which they will receive the tools to improve their sleep. | Behavioural | 10-Week CBT-I, 4-Week CBT-I |
Primary outcome
Insomnia Symptoms
Time frame: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
Total score on the Insomnia Severity Index (ISI), which ranges from 0-28. Higher scores indicate greater insomnia severity, while lower scores indicate less insomnia severity.
Sleep Continuity Disturbance
Time frame: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
Mean sleep latency, wake after sleep onset, and early morning awakenings (in minutes assessed via daily sleep diaries).
Total Sleep Time
Time frame: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
Mean sleep duration (in minutes) assessed via daily sleep diaries
HPA-Axis Functioning
Time frame: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).
Salivary cortisol assessed in three ways: hair (chronic stressor exposure), at-home saliva (basal cortisol), and saliva in response to an in-lab stressor (stress reactivity).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available upon completion of the study and publication of the study results. These data will be made available online through a dedicated study site.
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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.
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 in people with Chronic Insomnia, run by University of Notre Dame 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 3 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Vargas (574-631-5914, ivargas@nd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Symptoms (time frame: From enrollment through study completion - up to 7 months depending on assigned treatment group. Measured at Baseline, Pre-treatment, Post-Treatment, and Follow-Up (end of study).). The study lists 4 primary outcomes in all. 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 23 Apr 2026.