Sleep Stabilization + Light Therapy for Fibromyalgia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Chronic disease, Hearing problems, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Sleep Stabilization + Light Therapy for Fibromyalgia?
Light therapy has been shown to be effective in treating mood and sleep disturbances in various conditions, such as Seasonal Affective Disorder and insomnia, by improving sleep quality and mood. Additionally, morning light exposure has been found to enhance sleep quality and reduce daytime sleepiness in individuals with sleep disruptions.
12345Is Sleep Stabilization and Light Therapy safe for humans?
The research does not provide specific safety data for Sleep Stabilization and Light Therapy in humans, but these treatments are generally considered safe when used appropriately. Bright light therapy, often used for conditions like seasonal affective disorder, is typically well-tolerated, though it can cause mild side effects like eye strain or headaches.
678910How does the Sleep Stabilization + Light Therapy treatment for fibromyalgia differ from other treatments?
This treatment is unique because it combines sleep stabilization with light therapy, which uses exposure to specific light intensities to help regulate sleep patterns. Unlike traditional medications, this approach focuses on adjusting the body's internal clock and improving sleep quality, which may help alleviate fibromyalgia symptoms.
35111213Eligibility Criteria
This trial is for individuals with fibromyalgia or myofascial pain syndrome who are interested in exploring how sleep stabilization and morning light therapy might affect their symptoms. Specific eligibility criteria details were not provided.Inclusion Criteria
Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.
Meets 2016 revised diagnostic criteria for fibromyalgia (FM)
Exclusion Criteria
Significant chronic disease
Other research participation
Severe hearing or memory problems
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline
Participants' average wake-up time is recorded to tailor the timing of light therapy or sleep schedule
1 week
1 visit (virtual)
Treatment
Participants receive either morning light therapy or follow a fixed sleep schedule for 4 weeks
4 weeks
8 visits (virtual)
Follow-up
Participants are monitored for changes in fibromyalgia symptoms and pain levels after treatment
4 weeks
Participant Groups
The study is examining the effects of regulated sleep patterns and exposure to morning light therapy on fibromyalgia-related symptoms, aiming to understand if these interventions can provide relief.
3Treatment groups
Experimental Treatment
Active Control
Group I: Sleep StabilizationExperimental Treatment1 Intervention
All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the sleep stabilization arm are asked to follow a fixed sleep schedule tailored to their sleep during a baseline period. The treatment period is 4 weeks.
Group II: Light TherapyExperimental Treatment1 Intervention
All participants will be asked to attend 8 virtual visits over 5 months.
Participants randomized to the morning light therapy group are asked to wear the glasses for 1 hour per day. The timing of each person's therapy is tailored to their average wake up time during a baseline period. The treatment period is 4 weeks long.
Group III: Control Group, treatment as usualActive Control1 Intervention
Participants will be asked to sleep as per usual.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]Light therapy has become established as an evidence-based treatment for Seasonal Affective Disorder. Light impacts the timing and stability of circadian rhythms as expressed in sleep, mood, alertness, and cognition. Forty years of clinical trials and open treatment have led to guidelines for patient selection, using light alone or in combination with antidepressants (or lithium for bipolar depression). Mood and sleep disturbances can also respond to adjunct light therapy in a broader set of psychiatric, neurologic and medical illnesses. We specify criteria for choice of treatment devices: optimum dose (10,000 lux), spectrum (white light), exposure duration (30-60 minutes) and timing (early morning). Protocol adjustment requires continual monitoring with attention to rate of improvement and management of potential side effects.
Light therapy in insomnia disorder: A systematic review and meta-analysis. [2023]In the management of insomnia, physicians and patients are seeking alternative therapeutics to sleeping pills, in addition to sleep hygiene and cognitive behavioural therapy. Bright light therapy (LT) has proven its efficacy in circadian and mood disorders. We conducted a systematic literature review and meta-analysis according to Cochrane and PRISMA guidelines and using the databases Medline, Cochrane, and Web of Science, with a special focus on light therapy and insomnia. Twenty-two studies with a total of 685 participants were included, five of which with a high level of proof. Meta-analysis was performed with 13 of them: light therapy for insomnia compared with control conditions significantly improved wake after sleep onset (WASO: SMD = -0.61 [-1.11, -0.11]; p = 0.017; weighted difference of 11.2 min ±11.5 based on actigraphy, and SMD = -1.09 [-1.43, -0.74] (p
The Effect of Light Therapy on Electroencephalographic Sleep in Sleep and Circadian Rhythm Disorders: A Scoping Review. [2023]Light therapy is used to treat sleep and circadian rhythm disorders, yet there are limited studies on whether light therapy impacts electroencephalographic (EEG) activity during sleep. Therefore, we aimed to provide an overview of research studies that examined the effects of light therapy on sleep macro- and micro-architecture in populations with sleep and circadian rhythm disorders. We searched for randomized controlled trials that used light therapy and included EEG sleep measures using MEDLINE, PubMed, CINAHL, PsycINFO and Cochrane Central Register of Controlled Trials databases. Five articles met the inclusion criteria of patients with either insomnia or delayed sleep−wake phase disorder (DSWPD). These trials reported sleep macro-architecture outcomes using EEG or polysomnography. Three insomnia trials showed no effect of the timing or intensity of light therapy on total sleep time, wake after sleep onset, sleep efficiency and sleep stage duration compared to controls. Only one insomnia trial reported significantly higher sleep efficiency after evening light therapy (>4000 lx between 21:00−23:00 h) compared with afternoon light therapy (>4000 lx between 15:00−17:00 h). In the only DSWPD trial, six multiple sleep latency tests were conducted across the day (09:00 and 19:00 h) and bright light (2500 lx) significantly lengthened sleep latency in the morning (09:00 and 11:00 h) compared to control light (300 lx). None of the five trials reported any sleep micro-architecture measures. Overall, there was limited research about the effect of light therapy on EEG sleep measures, and studies were confined to patients with insomnia and DSWPD only. More research is needed to better understand whether lighting interventions in clinical populations affect sleep macro- and micro-architecture and objective sleep timing and quality.
Daily Morning Blue Light Therapy Improves Daytime Sleepiness, Sleep Quality, and Quality of Life Following a Mild Traumatic Brain Injury. [2021]Identify the treatment effects of 6 weeks of daily 30-minute sessions of morning blue light therapy compared with placebo amber light therapy in the treatment of sleep disruption following mild traumatic brain injury.
Illuminating rationale and uses for light therapy. [2021]Light therapy is increasingly applied in a variety of sleep medicine and psychiatric conditions including circadian rhythm sleep disorders, seasonal affective disorder, and dementia. This article reviews the neural underpinnings of circadian neurobiology crucial for understanding the influence of light therapy on brain function, common mood and sleep disorders in which light therapy may be effectively used, and applications of light therapy in clinical practice.
Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. [2021]Sleep disturbances play an important role in the exacerbation of pain and other troubling symptoms reported by patients with fibromyalgia (FM). The objective of this trial was to analyze the efficacy of a cognitive-behavioral therapy for insomnia (CBT-I) versus a sleep hygiene (SH) education program at improving sleep and other clinical manifestations in FM. Sixty-four FM women with insomnia were randomly assigned to the CBT-I or the SH groups, and 59 completed the treatments (30 in the CBT-I group and 29 in the SH group). Participants completed several self-report questionnaires at pre-, post-treatment and follow-ups. The CBT-I group reported significant improvements at post-treatment in several sleep variables, fatigue, daily functioning, pain catastrophizing, anxiety and depression. The SH group only improved significantly in subjective sleep quality. Patients in the CBT-I group showed significantly greater changes than those in the SH group in most outcome measures. The findings underscore the usefulness of CBT-I in the multidisciplinary management of FM.
The relationship between chronotype, sleep disturbance, severity of fibromyalgia, and quality of life in patients with fibromyalgia. [2021]Patients with fibromyalgia (FM) report high levels of sleep disturbance and chronic diffuse musculoskeletal pain. These patients experience diminished quality of life (QoL) due to pain and other comorbidities. Chronotype preferences have been suggested as a potential factor connecting increased severity of FM, sleep disturbances, and poor overall QoL. The present study is the first study examining the possible association between chronotype preferences, sleep disturbance, severity of FM, and QoL in patients with FM.One hundred drug-free patients diagnosed with FM participated in this cross-sectional study. Of them, 79 (79%) were females and 21 (21%) were males. The mean age was 41.65 ± 9.17 years (range: 21-62 years). The severity of FM symptoms, chronotype preferences, and QoL was evaluated using the Fibromyalgia Impact Questionnaire (FIQ), Morningness-Eveningness Questionnaire (MEQ), and World Health Organization Questionnaire on Quality of Life: Short Form (WHOQOL-BREF). The participants' anxiety/depressive symptoms and sleep problems were assessed using the Hospital Anxiety and Depression Scale (HADS) and Pittsburgh Sleep Quality Index (PSQI).The participants were classified according to their MEQ scores as evening type (score: 16-41), neither type (score: 42-58), and morning type (score: 59-86). It was found that there were significant differences in the FIQ score between the three groups (p < .001). It was determined that the total PSQI score was significantly higher in the evening type than the other two types (p < .05). It was found that there were significant differences in the general health, physical health, psychological, and environmental domain scores of the WHOQOL-BREF between the three groups (p < .05). It was detected that there were significant correlations between MEQ scores, WHOQOL-BREF subscale scores, FIQ scores, HADS-A and HADS-D scores, and PSQI scores. According to hierarchical regression analysis, eveningness preference explained an additional 21.9% of the variation in FM severity, thereby causing a statistically significant change in R-squared.Our results indicated that eveningness preference was directly related to increased FM symptom severity and poorer QoL. Based on these findings, neglecting to take chronotype preference into account may not result in optimal response to standard treatment for some patients with FM.
Assessment of sleep in patients with fibromyalgia: qualitative development of the fibromyalgia sleep diary. [2021]Sleep disturbance is a common experience in fibromyalgia (FM). The field lacks a sleep specific patient reported outcome (PRO) measure developed and validated in a FM population. The study objective is to gain an in-depth understanding of sleep in FM and to develop a PRO measure of it.
Reliability of a 1-week recall period for the Medical Outcomes Study Sleep Scale (MOS-SS) in patients with fibromyalgia. [2021]To evaluate the reliability of a one-week versus a four-week recall period of the Medical Outcomes Study Sleep Scale (MOS-SS) in patients with fibromyalgia (FM).
Morning Versus Evening Bright Light Treatment at Home to Improve Function and Pain Sensitivity for Women with Fibromyalgia: A Pilot Study. [2018]To test the feasibility, acceptability, and effects of a home-based morning versus evening bright light treatment on function and pain sensitivity in women with fibromyalgia.
Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial. [2022]Mild traumatic brain injury (TBI) is associated with persistent sleep-wake dysfunction, including insomnia and circadian rhythm disruption, which can exacerbate functional outcomes including mood, pain, and quality of life. Present therapies to treat sleep-wake disturbances in those with TBI (e.g., cognitive behavioral therapy for insomnia) are limited by marginal efficacy, poor patient acceptability, and/or high patient/provider burden. Thus, this study aimed to assess the feasibility and preliminary efficacy of morning bright light therapy, to improve sleep in Veterans with TBI (NCT03578003). Thirty-three Veterans with history of TBI were prospectively enrolled in a single-arm, open-label intervention using a lightbox (~10,000 lux at the eye) for 60-minutes every morning for 4-weeks. Pre- and post-intervention outcomes included questionnaires related to sleep, mood, TBI, post-traumatic stress disorder (PTSD), and pain; wrist actigraphy as a proxy for objective sleep; and blood-based biomarkers related to TBI/sleep. The protocol was rated favorably by ~75% of participants, with adherence to the lightbox and actigraphy being ~87% and 97%, respectively. Post-intervention improvements were observed in self-reported symptoms related to insomnia, mood, and pain; actigraphy-derived measures of sleep; and blood-based biomarkers related to peripheral inflammatory balance. The severity of comorbid PTSD was a significant positive predictor of response to treatment. Morning bright light therapy is a feasible and acceptable intervention that shows preliminary efficacy to treat disrupted sleep in Veterans with TBI. A full-scale randomized, placebo-controlled study with longitudinal follow-up is warranted to assess the efficacy of morning bright light therapy to improve sleep, biomarkers, and other TBI related symptoms.
Development of a Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury: Two Case Studies. [2021]Background and Objectives: Fatigue and sleep disturbance negatively impact quality of life following brain injury and there are no established treatments. Building on research showing efficacy of blue light therapy delivered via a lightbox in reducing fatigue and daytime sleepiness after traumatic brain injury (TBI), this paper describes the development and implementation of a novel in-home light therapy to alleviate fatigue and sleep disturbance in two case studies. Methods: During the 8-week lighting intervention, participants' home lighting was adjusted to provide high intensity, blue-enriched (high melanopic) light all day as a stimulant and dimmer, blue-depleted (low melanopic) light for 3 h before sleep as a soporific. The sham 8-week control condition resembled participants' usual (baseline) lighting conditions (3,000-4,000 K all day). Lighting conditions were crossed-over. Outcomes were measures of fatigue, subjective daytime sleepiness, sleep quality, insomnia symptoms, psychomotor vigilance and mood. Case study participants were a 35-year old male (5 years post-TBI), and a 46-year-old female (22 years post-TBI). Results: The relative proportion of melanopic lux was greater in Treatment lighting than Control during daytime, and lower during evenings. Participants found treatment to be feasible to implement, and was well-tolerated with no serious side effects noted. Self-reported compliance was >70%. Both cases demonstrated reduced fatigue, sleep disturbance and insomnia symptoms during the treatment lighting intervention. Case 2 additionally showed reductions in daytime sleepiness and depressive symptoms. As expected, symptoms trended toward baseline levels during the control condition. Discussion: Treatment was positively received and compliance rates were high, with no problematic side-effects. Participants expressed interest in continuing the ambient light therapy in their daily lives. Conclusions: These cases studies demonstrate the acceptability and feasibility of implementing a personalized in-home dynamic light treatment for TBI patients, with evidence for efficacy in reducing fatigue and sleep disturbance. Clinical Trial Registration:www.anzctr.org.au, identifier: ACTRN12617000866303.
Practice parameters for the use of light therapy in the treatment of sleep disorders. Standards of Practice Committee, American Academy of Sleep Medicine. [2019]These clinical guidelines were developed by the Standards of Practice Committee and reviewed and approved by the Board of Directors of the American Academy of Sleep Medicine. The guidelines provide recommendations for the practice of sleep medicine in North America regarding the use of light therapy for treatment of various sleep disorders. This paper is based on a series of articles in the Journal of Biological Rhythms and also includes evidence tables from an updated Medline review covering the period January 1994 to December 1997. Evidence is presented by grade and level. Recommendations are identified as standards, guidelines, or options. Recommendations are provided for delayed sleep phase syndrome (DSPS), advanced sleep phase syndrome (ASPS), non-24-hour sleep-wake syndrome, jet lag, shift work, dementia, and sleep complaints in the healthy elderly. Light therapy appears generally safe if used within recommended intensity and time limits. Light therapy can be useful in treatment of DSPS and ASPS. Benefits of light therapy are less clear and treatment is an option in jet lag, shift work, and non-24-hour sleep-wake syndrome in some blind patients.