- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01557062
Passive Body Heating, Sleep and Fibromyalgia
Passive Body Heating Improves The Sleep Pattern In Women Patients Fibromyalgia
Objectives: To assess the effect of passive body heating on the sleep pattern of patients with fibromyalgia.
Methods: Six menopausal women diagnosed with fibromyalgia according to criteria determined by the American College of Rheumatology were included. All women underwent passive immersion in a warm bath at 36±1 °C, for 15 sessions of 30 minutes each over 3 weeks. Their sleep pattern was assessed by polysomnography at the following conditions: pre-intervention (baseline), on the first day of intervention (acute), on the last day of intervention (chronic) and 3 weeks after the end of interventions (follow-up). Core body temperature was evaluated by a thermistor pill at the above-mentioned conditions. The impact on fibromyalgia was assessed through of a specific questionnaire called fibromyalgia impact questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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SP
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Sao Paulo, SP, Brazil, 04020-050
- Federal University of São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fibromyalgia diagnostic
- Women
- Post menopausal
- Sedentary
Exclusion Criteria:
- Other diagnosis of chronic illnesses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Polysomnography
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The Embla® S7000 was used to record full-night at the Sleep Institute (São Paulo, Brazil).
The sensors were attached to the patient in a non-invasive manner using tape or rubber bands.
The physiological variables were monitored simultaneously and continuously: 4 channels of EEG, 2 of EOG, 4 of EMG and 1 channel of ECG.
Airflow detection was made through 2 channels using a pair of thermal sensors and nasal pressure.
Respiratory effort of the chest and abdomen, were measured by respiratory inductance plethysmography.
Oxygen saturation, were measured with a pulse oximeter.
Sleep stages were visually scored in all the PSG according to standardized criteria for the investigation of sleep macrostructure.
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Other: Temperature measure
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Core body temperature was assessed using a thermistor pill (sensor), which is an electronic device 2.23 cm in length and 1.06 cm in diameter that records body temperature and transmits it to a receptor located at the patient's waist called the Core Body Temperature Monitoring System (CorTempTM), that is powered by a silver oxide battery.
The components of the sensor are encapsulated in epoxy resin and coated with silicone (HQ Inc., Florida, USA).
To ensure that the sensor would be in the intestines and not the stomach, the pill was ingested at least 2 hours (h) before beginning temperature recording.
The CBT was recorded every 30 minutes (min) between 10:00pm and 7:00am.
The time of pill elimination is variable between individuals and may be as long as 48h.
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Other: Fibromyalgia Impact questionary
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The FIQ is an instrument used to assess the quality of life specifically for patients with FM.
This questionnaire consists of 19 questions related to functional capacity, employment status, general well being, psychological disorders and physical symptoms.
The higher the score is, the greater is the impact of FM in the individual's quality of life.
This questionnaire was validated for Brazilian's population in 2006.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Pattern
Time Frame: 7 weeks. Was measured the sleep parameters from: Baseline to acute's time point (at the first day of intervention); Acute to chronic's time point (after 15 sections); Chronic's to follow-up time point (at 15 days after end point of interventions).
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Polysomnographies's register
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7 weeks. Was measured the sleep parameters from: Baseline to acute's time point (at the first day of intervention); Acute to chronic's time point (after 15 sections); Chronic's to follow-up time point (at 15 days after end point of interventions).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Fibromyalgia Disease
Time Frame: 7 weeks- The measurements occurred at the following time points: baseline, chronic and follow-up.
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Fibromyalgia Impact Questionnaire (FIQ)
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7 weeks- The measurements occurred at the following time points: baseline, chronic and follow-up.
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Changes in Core Body Temperature (CBT)
Time Frame: 7 weeks. Was measured the CBT from: Baseline to acute's time point (at the first day of intervention); Acute to chronic's time point (after 15 sections); Chronic's to follow-up time point (at 15 days after end point of interventions).
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was monitored continuously throughout the nights at baseline and on days of the experimental protocols by a thermistor pill with a CorTemp HT150002 and core temperature sensor coupled with a data recorder.
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7 weeks. Was measured the CBT from: Baseline to acute's time point (at the first day of intervention); Acute to chronic's time point (after 15 sections); Chronic's to follow-up time point (at 15 days after end point of interventions).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco T De Mello, Ph.D, Federal University of São Paulo
- Study Chair: Adressa Silva, MD, Federal University of São Paulo
- Study Chair: Sandra S Queiroz, Federal University of São Paulo
- Study Chair: Mônica L Andersen, Ph.D, Federal University of São Paulo
- Study Chair: Marcos Mônico-Neto, Federal University of São Paulo
- Study Chair: Raquel MS Campos, MD, Federal University of São Paulo
- Study Chair: Suely Roizenblatt, Ph.D, Federal University of São Paulo
- Study Chair: Sergio Tufik, Ph.D, Federal University of São Paulo
Publications and helpful links
General Publications
- Evcik D, Kizilay B, Gokcen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. doi: 10.1007/s00296-002-0189-8. Epub 2002 Mar 29.
- Vitorino DF, Carvalho LB, Prado GF. Hydrotherapy and conventional physiotherapy improve total sleep time and quality of life of fibromyalgia patients: randomized clinical trial. Sleep Med. 2006 Apr;7(3):293-6. doi: 10.1016/j.sleep.2005.09.002. Epub 2006 Mar 24.
- Langhorst J, Musial F, Klose P, Hauser W. Efficacy of hydrotherapy in fibromyalgia syndrome--a meta-analysis of randomized controlled clinical trials. Rheumatology (Oxford). 2009 Sep;48(9):1155-9. doi: 10.1093/rheumatology/kep182. Epub 2009 Jul 16.
- Bunnell DE, Agnew JA, Horvath SM, Jopson L, Wills M. Passive body heating and sleep: influence of proximity to sleep. Sleep. 1988 Apr;11(2):210-9. doi: 10.1093/sleep/11.2.210.
- Jordan J, Montgomery I, Trinder J. The effect of afternoon body heating on body temperature and slow wave sleep. Psychophysiology. 1990 Sep;27(5):560-6. doi: 10.1111/j.1469-8986.1990.tb01976.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fibromyalgia_0866/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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