A Phase 4 interventional study of suvorexant and placebo in Insomnia and Fibromyalgia, sponsored by Henry Ford Health System. Terminated at 1 site in United States. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-16.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
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.
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).
1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
9 nights of 20 mg suvorexant
Drug: suvorexant
9 nights placebo
Drug: placebo
suvorexant 20 mg taken before sleep
Also known as: belsomra
placebo taken before sleep
Also known as: matching placebo
Polysomnographic Assessment of Sleep
total sleep time on 8 hr standard sleep recording
Time frame: continuous sleep recording from 11pm to 7am on night 8
Daytime Pain Sensitivity
finger withdrawal response to a radiant heat stimulus when pain is first experienced
Time frame: mean of tests at 1100 and 1500 hrs on both day 1 and day 8
| Milestone | Suvorexant First, Then Placebo | Placebo First, Then Suvorexant |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
| Milestone | Suvorexant First, Then Placebo | Placebo First, Then Suvorexant |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
| Milestone | Suvorexant First, Then Placebo | Placebo First, Then Suvorexant |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
total sleep time on 8 hr standard sleep recording
| min | Suvorexant | Placebo |
|---|---|---|
| Polysomnographic Assessment of Sleep | 429.3 ± 29.4 | 400.5 ± 57.3 |
finger withdrawal response to a radiant heat stimulus when pain is first experienced
| sec | Suvorexant | Placebo |
|---|---|---|
| Daytime Pain Sensitivity | 15.8 ± 5.4 | 14.7 ± 4.9 |
Collected over nightly over the 9 nights. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Suvorexant | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Placebo | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Suvorexant | Placebo |
|---|---|---|
| headacheNervous system disorders | 8/10 | 3/10 |
this is a crossover study
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 50.1 ± 9.1 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 10 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Total Sleep Time(min of total sleep time on a 8-hr PSG) | All Study Participants |
|---|---|
| Mean | 346.9 ± 52.32 |
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