InsomniaPhase 4NCT03034018
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
A Phase 4 study testing suvorexant in people with Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- suvorexant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 3 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peri- or postmenopausal women
- DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
- Some awakenings co-occur with a hot flash
- Score on the Insomnia Severity Index (ISI) measure ≥15
- Hot flashes present, including at night
Who cannot join
- Diagnosis of other primary sleep disorders
- Shift workers
- Current or expected use of hypnotic medications
- Current major depressive episode
- Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
- Current alcohol/substance use disorder
Show all 17Show fewer
- Obesity
- Renal or hepatic disease
- Pregnancy or breastfeeding
- Recent malignancy
- Recent surgery
- Neurological disorder or cardiovascular disease raising safety concerns
- Medical instability considered to interfere with study procedures
- Concomitant medications with drug interaction or co-administration concerns
- Contraindications or allergic responses to suvorexant
- Recent or planned travel across time zones
- Excessive coffee or cigarette use
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
- Conditions
- Insomnia
- Being tested
- suvorexant, placebo
- Keywords
- insomnia, hot flashes, menopause, suvorexant, belsomra
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suvorexantDrug
Also called Belsomra
10-20 mg taken at bedtime for four weeks
placeboDrug
placebo taken at bedtime for four weeks
| Study group | Role | What they receive |
|---|---|---|
| suvorexant | Experimental | suvorexant 10-20 mg taken at bedtime for four weeks Receives: Drug: suvorexant |
| placebo | Placebo comparator | placebo taken at bedtime for four weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-person Change in ISI Score
The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start25 May 2017
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadine Joffe, MD MSc, Brigham and Women's Hospital
- Investigators
- Hadine Joffe, MD MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034018
- Sponsor's protocol ID
- 2016P002667
- Status last verified
- Mar 2022
- First submitted
- 25 Jan 2017
- Last updated
- 14 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rahman SA, Nathan MD, Wiley A, Crawford S, Cohn AY, Harder JA, Grant LK, Erickson A, Srivastava A, McCormick K, Bertisch SM, Winkelman JW, Joffe H. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women. Sleep. 2022 Mar 14;45(3):zsac007. doi: 10.1093/sleep/zsac007.
PubMed 35022783
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women
- ClinicalTrials.gov ID
- NCT03034018
- Acronym / sponsor ID
- 2016P002667
- Conditions
- Insomnia
- Keywords
- insomnia, hot flashes, menopause, suvorexant, belsomra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suvorexant | Experimental | Drug: suvorexantsuvorexant 10-20 mg taken at bedtime for four weeks |
| placebo | Placebo comparator | Drug: placeboplacebo taken at bedtime for four weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Peri- or postmenopausal women
- DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
- Some awakenings co-occur with a hot flash
- Score on the Insomnia Severity Index (ISI) measure ≥15
- Hot flashes present, including at night
Key exclusion criteria (17 listed)
- Diagnosis of other primary sleep disorders
- Shift workers
- Current or expected use of hypnotic medications
- Current major depressive episode
- Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
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 |
|---|---|---|
| suvorexantAlso: Belsomra10-20 mg taken at bedtime for four weeks | Drug | suvorexant |
| placeboplacebo taken at bedtime for four weeks | Drug | placebo |
Primary outcome
Within-person Change in ISI Score
Time frame: baseline and 4 weeks
The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35022783Rahman SA, Nathan MD, Wiley A, Crawford S, Cohn AY, Harder JA, Grant LK, Erickson A, Srivastava A, McCormick K, Bertisch SM, Winkelman JW, Joffe H. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women. Sleep. 2022 Mar 14;45(3):zsac007. doi: 10.1093/sleep/zsac007.
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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.
Hadine Joffe, MD MSc principal investigator
Brigham and Women's Hospital
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 Insomnia, run by Brigham and Women's Hospital 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 17 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 14 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Within-person Change in ISI Score (time frame: baseline and 4 weeks). 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 NCT03034018, which also lists 1 linked publication.
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 14 Mar 2022.