Chronic InsomniaPhase 4NCT03768713
Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia
A Phase 4 study testing Suvorexant in people with Chronic Insomnia, run by Montana State University at 1 site in United States.
Trial summary
This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and baroreflex function in subject with chronic insomnia. The investigator's central hypothesis is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to Apr 2023
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 3 months of clinically diagnosed insomnia
- Body mass index ≤35 kg/m2
- Insomnia Severity Index (ISI) > 7 arbitrary units (i.e., mild-to-severe insomnia)
- Pre-menopausal women must have regular menstrual cycles (~26-30 day cycles) and will be scheduled for microneurography 2-7 days after menstruation to consistently test during the early follicular phase (or low-hormone phase in women on contraceptives)
Who cannot join
- Current or prior treatment of Suvorexant.
- Obstructive sleep apnea defined as an apnea-hypopnea index > 30 using an FDA approved home sleep apnea screening devices as used in routine clinical practice.
- Participants without evidence of clinically significant obstructive sleep apnea on the screening test will undergo an overnight in-laboratory polysomnography to confirm absence of sleep apnea (apnea-hypopnea index of ≥ 30 episodes per hour) and to exclude other sleep disorders (e.g. periodic limb movement arousal index of ≥ 5 episodes per hour)
- Circadian rhythm sleep disorders
- History of meeting DSM-V criteria of major psychiatric disorder
- Have been clinically-diagnosed with diabetes, cardiovascular disease, or any other unstable or serious medical condition.
Show all 11Show fewer
- Current, or use within past month, of psychoactive (other than stable treatment with antidepressant or antianxiety), hypnotic, stimulant or analgesic medication (except occasional non-narcotic analgesics)
- Shift work or other types of self-imposed irregular sleep schedules
- Habitual smoking (6 or more cigarettes per week)
- Habitual alcohol consumption (more than 2 alcoholic drinks per day)
- Breastfeeding or pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Montana State University
Bozeman, Montana, 59717
Anne Tikkanen, 406-994-2292, anne.tikkanen@montana.edu
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Suvorexant (Belsomra®) on Sympathetic Neural Activity and Baroreflex Function in Patients With Chronic Insomnia
This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and baroreflex function in subject with chronic insomnia. The investigator's central hypothesis is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo.
Read the detailed description
This study will utilize a randomized, double-blind, placebo-controlled experimental approach to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve activity and baroreflex function in male and female subjects with chronic insomnia. The study will utilize established techniques for assessing sleep (polysomnography), blood pressure (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve activity (microneurography). The study will stratify enrollment based upon both age and sex (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve activity and baroreflex function.
- Conditions
- Chronic Insomnia
- Being tested
- Suvorexant, Placebo
- 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.
SuvorexantDrug
Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.
PlaceboDrug
Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Drug (Suvorexant) | Experimental | 20 mg of Suvorexant daily (taken orally ~1 hour before bedtime) Receives: Drug: Suvorexant |
| Placebo | Placebo comparator | 20 mg of Placebo daily (taken orally ~1 hour before bedtime) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic nerve activity
Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
Measured: 8 weeks
Baroreflex sensitivity
The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.
Measured: 8 weeks
Secondary outcomes (3)
Sympathetic reactivity
The change in muscle sympathetic nerve activity during a cold pressor test.
Measured: 8 weeks
Home sleep quality: Wrist actigraphy
Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.
Measured: 8 weeks
Laboratory sleep quality: Polysomnography
Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start18 Apr 2019
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Sponsor
- Investigators
- Jason Carter, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768713
- Sponsor's protocol ID
- JC101320-FC
- Status last verified
- Oct 2021
- First submitted
- 5 Dec 2018
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Suvorexant (Belsomra®) on Sympathetic Neural Activity and Baroreflex Function in Patients With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT03768713
- Acronym / sponsor ID
- JC101320-FC
- Conditions
- Chronic Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 7 Dec 2018 (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.
This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and baroreflex function in subject with chronic insomnia. The investigator's central hypothesis is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo.
Detailed description
This study will utilize a randomized, double-blind, placebo-controlled experimental approach to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve activity and baroreflex function in male and female subjects with chronic insomnia. The study will utilize established techniques for assessing sleep (polysomnography), blood pressure (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve activity (microneurography). The study will stratify enrollment based upon both age and sex (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve activity and baroreflex function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug (Suvorexant) | Experimental | Drug: Suvorexant20 mg of Suvorexant daily (taken orally ~1 hour before bedtime) |
| Placebo | Placebo comparator | Drug: Placebo20 mg of Placebo daily (taken orally ~1 hour before bedtime) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum 3 months of clinically diagnosed insomnia
- Body mass index ≤35 kg/m2
- Insomnia Severity Index (ISI) > 7 arbitrary units (i.e., mild-to-severe insomnia)
- Pre-menopausal women must have regular menstrual cycles (~26-30 day cycles) and will be scheduled for microneurography 2-7 days after menstruation to consistently test during the early follicular phase (or low-hormone phase in women on contraceptives)
Key exclusion criteria (11 listed)
- Current or prior treatment of Suvorexant.
- Obstructive sleep apnea defined as an apnea-hypopnea index > 30 using an FDA approved home sleep apnea screening devices as used in routine clinical practice.
- Participants without evidence of clinically significant obstructive sleep apnea on the screening test will undergo an overnight in-laboratory polysomnography to confirm absence of sleep apnea (apnea-hypopnea index of ≥ 30 episodes per hour) and to exclude other sleep disorders (e.g. periodic limb movement arousal index of ≥ 5 episodes per hour)
- Circadian rhythm sleep disorders
- History of meeting DSM-V criteria of major psychiatric disorder
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 |
|---|---|---|
| SuvorexantInsomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks. | Drug | Drug (Suvorexant) |
| PlaceboInsomnia subjects will take a nightly pill of 20 mg placebo for eight weeks. | Drug | Placebo |
Primary outcome
Sympathetic nerve activity
Time frame: 8 weeks
Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
Baroreflex sensitivity
Time frame: 8 weeks
The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.
3 secondary outcomes
Sympathetic reactivity
Time frame: 8 weeks
Home sleep quality: Wrist actigraphy
Time frame: 8 weeks
Laboratory sleep quality: Polysomnography
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- 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.
Jason Carter, PhD principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suvorexant in people with Chronic Insomnia, run by Montana State University 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 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 7 Oct 2021. 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tikkanen (406-994-2292, anne.tikkanen@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic nerve activity (time frame: 8 weeks). 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?
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 7 Oct 2021.