InsomniaPhase 4NCT02684136
Suvorexant in Insomnia Co-morbid With Fibromyalgia
A Phase 4 study testing suvorexant in people with Insomnia and Fibromyalgia, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Insomnia, Fibromyalgia
- What is being tested?
- suvorexant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 1 Jul 2018
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet Diagnostic and Statistical Manual 5th ed criteria for insomnia
- meet American College of Rheumatology criteria for fibromyalgia
- otherwise good psychiatric and stable physical health
Who cannot join
- other primary sleep disorders
- pain symptoms unrelated to fibromyalgia
- current pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Crossover, Study to Compare the Hypnotic, Daytime Sleepiness/Fatigue, and Pain Effects of Nighttime Administration of Suvorexant 20 mg Versus Placebo in Patients With Fibromyalgia and Comorbid Insomnia
This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.
Read the detailed description
It has now become clear that the relation of sleep and pain is bidirectional; acute and chronic pain is associated with disturbed sleep and disturbed sleep enhances pain. Experimental studies have shown that reduced and fragmented sleep in pain-free normals increases their pain sensitivity and daily self-report studies in chronic pain patients have shown a poor night of sleep is followed by enhanced next-day pain. In mediation analyses of large clinical data sets it is found that the sleep-pain side of the bidirectional relation, as opposed to the pain-sleep side, accounts for the greater variance. These data then would suggest that improving sleep in chronic pain disorders should attenuate daytime pain.
Most of the drugs used to treat chronic pain facilitate inhibitory central nervous system mechanisms as their primary mechanism of action. Suvorexant, recently approved by the FDA for the treatment of insomnia characterized by difficulties with sleep onset and sleep maintenance, has a unique mechanism of action. Suvorexant is a selective antagonist for orexin receptors (OX1R and OX2R). Orexins are considered to be involved in arousal and maintenance of the waking state.
As such, suvorexant may provide unique clinical benefit as a treatment in chronic pain conditions with co-morbid insomnia, and specifically for fibromyalgia with its putative central hyperarousal and hypersensitization. Thus, this project proposes to study objective and clinical measures of sleep, pain, and daytime sleepiness and fatigue in patients with fibromyalgia and co-morbid insomnia while treated short-term with suvorexant 20 mg versus placebo.
Those qualifying will receive suvorexant 20 mg and placebo for each of 9 nights in a cross over design with 7 nights of washout between treatments. Overnight sleep recordings (PSGs) will be collected on nights 7 and 8 of each crossover treatment arm to determine objective sleep measures. During the day following night 7 in each arm, a Multiple Sleep Latency Test (MSLT) at 1000, 1200, 1400, and 1600 hr will be conducted and nociceptive sensitivity [finger withdrawal latency (FWL)] testing to a radiant heat stimulus (1100 and 1500 hr) will be conducted on day 1 and day 8. Self-reported mood and pain indices will also be completed prior to each FWL test.
Primary outcomes to be measured include PSG sleep efficacy and FWL response on both conditions (suvorexant 20 mg versus placebo).
- Conditions
- Insomnia, Fibromyalgia
- Being tested
- suvorexant, placebo
- Keywords
- insomnia, fibromyalgia, polysomnography, pain management
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fibromyalgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suvorexantDrug
Also called belsomra
suvorexant 20 mg taken before sleep
placeboDrug
Also called matching placebo
placebo taken before sleep
| Study group | Role | What they receive |
|---|---|---|
| suvorexant | Experimental | 9 nights of 20 mg suvorexant Receives: Drug: suvorexant |
| placebo | Placebo comparator | 9 nights placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographic Assessment of Sleep
total sleep time on 8 hr standard sleep recording
Measured: continuous sleep recording from 11pm to 7am on night 8
Secondary outcomes (1)
Daytime Pain Sensitivity
finger withdrawal response to a radiant heat stimulus when pain is first experienced
Measured: mean of tests at 1100 and 1500 hrs on both day 1 and day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: reduced ability to recruit sufficient number of patients
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 (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Roehrs, PhD, Henry Ford Health System
- Investigators
- Timothy Roehrs, PhD, Principal investigator, Henry Ford Health SystemThomas Roth, PhD, Study chair, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684136
- Sponsor's protocol ID
- FM16
- Status last verified
- Apr 2021
- First submitted
- 22 Jan 2016
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783Roehrs T, Diederichs C, Gillis M, Burger AJ, Stout RA, Lumley MA, Roth T. Nocturnal sleep, daytime sleepiness and fatigue in fibromyalgia patients compared to rheumatoid arthritis patients and healthy controls: a preliminary study. Sleep Med. 2013 Jan;14(1):109-15. doi: 10.1016/j.sleep.2012.09.020. Epub 2012 Nov 11.
PubMed 23149217Roehrs T, Withrow D, Koshorek G, Verkler J, Bazan L, Roth T. Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo. J Clin Sleep Med. 2020 Mar 15;16(3):415-421. doi: 10.5664/jcsm.8220. Epub 2020 Jan 14.
PubMed 31992394
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Crossover, Study to Compare the Hypnotic, Daytime Sleepiness/Fatigue, and Pain Effects of Nighttime Administration of Suvorexant 20 mg Versus Placebo in Patients With Fibromyalgia and Comorbid Insomnia
- ClinicalTrials.gov ID
- NCT02684136
- Acronym / sponsor ID
- FM16
- Conditions
- Insomnia, Fibromyalgia
- Keywords
- insomnia, fibromyalgia, polysomnography, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: reduced ability to recruit sufficient number of patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Feb 2016
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.
Detailed description
It has now become clear that the relation of sleep and pain is bidirectional; acute and chronic pain is associated with disturbed sleep and disturbed sleep enhances pain. Experimental studies have shown that reduced and fragmented sleep in pain-free normals increases their pain sensitivity and daily self-report studies in chronic pain patients have shown a poor night of sleep is followed by enhanced next-day pain. In mediation analyses of large clinical data sets it is found that the sleep-pain side of the bidirectional relation, as opposed to the pain-sleep side, accounts for the greater variance. These data then would suggest that improving sleep in chronic pain disorders should attenuate daytime pain.
Most of the drugs used to treat chronic pain facilitate inhibitory central nervous system mechanisms as their primary mechanism of action. Suvorexant, recently approved by the FDA for the treatment of insomnia characterized by difficulties with sleep onset and sleep maintenance, has a unique mechanism of action. Suvorexant is a selective antagonist for orexin receptors (OX1R and OX2R). Orexins are considered to be involved in arousal and maintenance of the waking state.
As such, suvorexant may provide unique clinical benefit as a treatment in chronic pain conditions with co-morbid insomnia, and specifically for fibromyalgia with its putative central hyperarousal and hypersensitization. Thus, this project proposes to study objective and clinical measures of sleep, pain, and daytime sleepiness and fatigue in patients with fibromyalgia and co-morbid insomnia while treated short-term with suvorexant 20 mg versus placebo.
Those qualifying will receive suvorexant 20 mg and placebo for each of 9 nights in a cross over design with 7 nights of washout between treatments. Overnight sleep recordings (PSGs) will be collected on nights 7 and 8 of each crossover treatment arm to determine objective sleep measures. During the day following night 7 in each arm, a Multiple Sleep Latency Test (MSLT) at 1000, 1200, 1400, and 1600 hr will be conducted and nociceptive sensitivity [finger withdrawal latency (FWL)] testing to a radiant heat stimulus (1100 and 1500 hr) will be conducted on day 1 and day 8. Self-reported mood and pain indices will also be completed prior to each FWL test.
Primary outcomes to be measured include PSG sleep efficacy and FWL response on both conditions (suvorexant 20 mg versus placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suvorexant | Experimental | Drug: suvorexant9 nights of 20 mg suvorexant |
| placebo | Placebo comparator | Drug: placebo9 nights placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet Diagnostic and Statistical Manual 5th ed criteria for insomnia
- meet American College of Rheumatology criteria for fibromyalgia
- otherwise good psychiatric and stable physical health
Key exclusion criteria (3 listed)
- other primary sleep disorders
- pain symptoms unrelated to fibromyalgia
- current pregnancy or breast-feeding
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: belsomrasuvorexant 20 mg taken before sleep | Drug | suvorexant |
| placeboAlso: matching placeboplacebo taken before sleep | Drug | placebo |
Primary outcome
Polysomnographic Assessment of Sleep
Time frame: continuous sleep recording from 11pm to 7am on night 8
total sleep time on 8 hr standard sleep recording
1 secondary outcome
Daytime Pain Sensitivity
Time frame: mean of tests at 1100 and 1500 hrs on both day 1 and day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Background: PubMed 23149217Roehrs T, Diederichs C, Gillis M, Burger AJ, Stout RA, Lumley MA, Roth T. Nocturnal sleep, daytime sleepiness and fatigue in fibromyalgia patients compared to rheumatoid arthritis patients and healthy controls: a preliminary study. Sleep Med. 2013 Jan;14(1):109-15. doi: 10.1016/j.sleep.2012.09.020. Epub 2012 Nov 11.
- Derived from this study: PubMed 31992394Roehrs T, Withrow D, Koshorek G, Verkler J, Bazan L, Roth T. Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo. J Clin Sleep Med. 2020 Mar 15;16(3):415-421. doi: 10.5664/jcsm.8220. Epub 2020 Jan 14.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Timothy Roehrs, PhD principal investigator
Henry Ford Health System
Thomas Roth, PhD study chair
Henry Ford Health System
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 and Fibromyalgia, run by Henry Ford Health System 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 3 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: stopped early, as of the sponsor's last update on 16 Jun 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?
Yes. Results are posted in the registry (first posted 28 Apr 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?
Polysomnographic Assessment of Sleep (time frame: continuous sleep recording from 11pm to 7am on night 8). 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 NCT02684136, which also lists 3 linked publications.
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 16 Jun 2021.