InsomniaEarly Phase 1NCT06281756
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
A Early Phase 1 study testing Cognitive Behavioral Treatment for Insomnia (CBT-I) and Trazodone in people with Insomnia and Insomnia Chronic, run by Milton S. Hershey Medical Center at 4 sites in 2 countries.
Trial summary
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Insomnia Chronic, Insomnia, Primary
- What is being tested?
- Cognitive Behavioral Treatment for Insomnia (CBT-I) and Trazodone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Mar 2024to 31 May 2028
- Phase
- Early Phase 1
- 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
- Age 18 or older
- Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- Meets criteria for chronic insomnia
- Body Mass Index (BMI) 18.5 kg/m2 and higher
Who cannot join
- Age < 18
- Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- Unwilling to share email address/cell phone number to accept survey links.
- Life time diagnosis of psychotic or bipolar disorder
- History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
- Started new or changed treatment for sleep apnea in the past three months
Show all 24Show fewer
- Does not meet criteria for chronic insomnia
- Meets criteria for narcolepsy or hypersomnia disorder
- Meets criteria for circadian rhythm disorder (including night shift work)
- Unstable medical conditions that would make participation unsafe or unfeasible
- Falls resulting in hospitalization, significant injury or fracture within past 12 months
- 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
- Active chemotherapy or radiation therapy for cancer
- Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
- Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
- BMI less than 18.5
- Substance abuse or dependence in the past 12 months
- Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
- Current use of systemic corticosteroids or opiate medications
- Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
- Current use of medications contraindicated with trazodone
- Sleep apnea or periodic leg movement disorder as determined by sleep study
- Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
- EKG corrected QT interval greater than or equal to 500 ms
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206-2761
Roxane Horberg, 303-270-2850, horbergr@njhealth.org
Rachel Johnson, 303 398-1058, johnsonr@njhealth.org
- Recruiting
Penn State University
Hershey, Pennsylvania, 17033
Carrie Criley, 717-531-4123, ccriley@pennstatehealth.psu.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-3203
Laurie Brar, 412-723-7998, brarlk@upmc.edu
Canada1 site, 1 recruiting
- Recruiting
Université Laval
Québec, Quebec, G1V 0A6
Manon Lamy, 418 656-2131 ext. 412467, manon.lamy@psy.ulaval.ca
About this study
Official title: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
- Being tested
- Cognitive Behavioral Treatment for Insomnia (CBT-I), Trazodone, Placebo
- Keywords
- sleep, sleep disorder, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hypertension, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Treatment for Insomnia (CBT-I)Behavioural
Subjects will receive therapy for 8 weeks
TrazodoneDrug
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
PlaceboOther
Non-remitting subjects will receive placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo | Placebo comparator | Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks. Receives: Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I); Other: Placebo |
| Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone | Active comparator | Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks. Receives: Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I); Drug: Trazodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Measured: 9 weeks
Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Measured: 9 weeks
Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Measured: 35 weeks
Secondary outcomes (11)
Insomnia Severity Index (ISI) Score following CBT-I
0-28, with 0 being mild and 28 being severe
Measured: 9 weeks
Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study
Measured: 9 weeks
Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period)
Measured: 9 weeks
Evening Cortisol levels following CBT-I
Cortisol levels measured in saliva collected following CBT-I
Measured: 9 weeks
Insomnia Severity Index (ISI) Score following RCT
0-28, with 0 being mild and 28 being severe
Measured: 9 weeks
PSG Total Sleep Time (TST) following RCT
PSG Total Sleep Time measured in minutes asleep during sleep study following RCT
Measured: 9 weeks
Actigraphy Total Sleep Time (TST) following RCT
Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT
Measured: 9 weeks
Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)
Morning SBP Blood Pressure Readings measured at home (7 day period)
Measured: 9 weeks
Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)
Morning DBP Blood Pressure Readings measured at home (7 day period)
Measured: 9 weeks
Evening Cortisol levels following RCT
Cortisol levels measured in saliva collected following RCT
Measured: 9 weeks
Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment
Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment
Measured: 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Mar 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alexandros Vgontzas, Milton S. Hershey Medical Center
- Investigators
- Alexandros Vgontzas, MD, Principal investigator, Professor, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281756
- Sponsor's protocol ID
- STUDY00022285
- Other IDs
- 1UG3HL161342-01A1
- Status last verified
- Nov 2025
- First submitted
- 19 Feb 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators have extensive experience preparing data and documentation to be available for public. They agree to abide by the principles for sharing research resources described by the National Heart, Lung, Blood Institute (NHLBI). A copy of the data will be uploaded to the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) repository. The datasets will not include any personal identifiers related to participants or clinical sites. Dates will be de-identified through a date-shifting algorithm to mask actual dates while maintaining a relation to the epoch in which events occurred. Data tables will be exported in comma-separated format, readable by statistical software. Variable dictionaries and code books, detailing variable description, format, value domain and labels, will be produced. Raw data files for polysomnogram/actigraphy/cortisol will also be made available, ensuring that data are linkable to study data and data are de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06281756
- Acronym / sponsor ID
- STUDY00022285
- Keywords
- sleep, sleep disorder, insomnia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 28 Feb 2024 (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.
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters.
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo | Placebo comparator | Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I), Other: PlaceboSubjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks. |
| Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone | Active comparator | Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I), Drug: TrazodoneSubjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- Meets criteria for chronic insomnia
- Body Mass Index (BMI) 18.5 kg/m2 and higher
Key exclusion criteria (24 listed)
- Age < 18
- Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- Unwilling to share email address/cell phone number to accept survey links.
- Life time diagnosis of psychotic or bipolar disorder
- History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
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 Treatment for Insomnia (CBT-I)Subjects will receive therapy for 8 weeks | Behavioural | Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone, Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo |
| TrazodoneNon-remitting subjects will receive Trazodone (dosage) for 8 weeks | Drug | Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone |
| PlaceboNon-remitting subjects will receive placebo for 8 weeks | Other | Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo |
Primary outcome
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Time frame: 9 weeks
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)
Time frame: 9 weeks
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment
Time frame: 35 weeks
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
11 secondary outcomes
Insomnia Severity Index (ISI) Score following CBT-I
Time frame: 9 weeks
Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Time frame: 9 weeks
Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Time frame: 9 weeks
Evening Cortisol levels following CBT-I
Time frame: 9 weeks
Insomnia Severity Index (ISI) Score following RCT
Time frame: 9 weeks
PSG Total Sleep Time (TST) following RCT
Time frame: 9 weeks
Actigraphy Total Sleep Time (TST) following RCT
Time frame: 9 weeks
Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)
Time frame: 9 weeks
Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)
Time frame: 9 weeks
Evening Cortisol levels following RCT
Time frame: 9 weeks
Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment
Time frame: 35 weeks
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 10 Nov 2025.
- Individual participant dataSharing planned: Yes. The investigators have extensive experience preparing data and documentation to be available for public. They agree to abide by the principles for sharing research resources described by the National Heart, Lung, Blood Institute (NHLBI). A copy of the data will be uploaded to the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) repository. The datasets will not include any personal identifiers related to participants or clinical sites. Dates will be de-identified through a date-shifting algorithm to mask actual dates while maintaining a relation to the epoch in which events occurred. Data tables will be exported in comma-separated format, readable by statistical software. Variable dictionaries and code books, detailing variable description, format, value domain and labels, will be produced. Raw data files for polysomnogram/actigraphy/cortisol will also be made available, ensuring that data are linkable to study data and data are de-identified.
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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.
Alexandros Vgontzas, MD principal investigator
Professor, Psychiatry
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cognitive Behavioral Treatment for Insomnia (CBT-I) and Trazodone in people with Insomnia and Insomnia Chronic, run by Milton S. Hershey Medical Center at 4 sites in 2 countries.
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 24 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 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Carrie Criley (717-531-4123, ccriley@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) (time frame: 9 weeks). The study lists 3 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 10 Nov 2025.