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NCT Number: NCT06595771

Obstructive Sleep Apnea Syndrome and Fibromiyalgia

-------------Obstructive sleep apnea syndrome (OSAS) is a syndrome characterized by recurrent complete (apnea) or partial (hypopnea) upper respiratory tract obstruction episodes during sleep and a decrease in blood oxygen saturation. It has been suggested that nocturnal arterial desaturation in patients with OSAS is effective on pain. Intermittent hypoxia and oxidative stress occur in patients with OSAS. Intermittent hypoxia occurring in patients with OSAS causes increased levels of HIF-1-α and mitochondrial reactive oxygen products, resulting in the formation, processing, and formation of central and peripheral synthesis. When the literature is examined, pressure-related pain threshold was measured with algometer in female patients diagnosed with sleep apnea and in the control group, and it was found lower in patients with OSAS.

Fibromyalgia Syndrome (FMS) is a clinical picture with many symptoms such as chronic widespread pain, fatigue, sleep disturbance, cognitive dysfunction. Similar sleep patterns were observed in FMS and OSAS.

In addition to sleep symptoms such as the presence of a similar sleep pattern, a feeling of rest and daytime sleepiness in cases of OSAS and FMS, it has been suggested that these two diseases may be related to each other. Studies examining the relationship between OSAS and FMS syndrome, including sleep disturbance and pain symptoms, are rare in the literature. In the current literature, there are various limitations such as insufficient number of cases, significant difference between demographic characteristics such as gender, ethnicity, age.

Therefore, primary goal of this study is to investigate the association of FMS in patients diagnosed with OSAS. The secondary aim is to investigate the effect of CPAP (Continuous Positive Airway Pressure) treatment on pain sensitivity and symptom severity, functional level, depression in patients diagnosed with FMS, and to investigate the relationship between these parameters and polysomnographic data

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Key information

Conditions

Fibromyalgia, Primary Apnea Dyssomnias Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Respiration Disorders Respiratory Tract Diseases Rheumatic Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

Patients between 30-65 years of age who were diagnosed with OSAS according to American Academy of Sleep Medicine (AASM) criteria and who had clinical symptoms of OSAS for at least 1 year before diagnosis will be performed. All OSAS patients recommended and not recommended for CPAP treatment in the sleep clinic will be evaluated according to the American Rheumatology Association (ACR) 1990 and 2016 criteria for FMS. Patients meeting both criteria will be accepted as FMS.

Demographic data and polysomnographic data of patients such as age, height, weight, BMI, occupation, educational status (polysomnographic data (AHI, min. O₂ sat, O₂ saturation <90% elapsed time and percentage, sleep latency, sleep efficacy, REM, nREM1,2,3 polysomnographic data such as times, REM latency, severity of OSAS) will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being between the ages of 1-30-65
  • Being diagnosed with Obstructive Sleep apnea syndrome and/or having CPAP treatment indication

Exclusion criteria

  • Chronic inflammatory or autoimmune disease
  • hyperthyroidism/hyperthyroidism
  • Cognitive dysfunction (such as dementia)
  • Severe psychiatric disorder
  • Antidepressant medication used in the last 2 weeks
  • Non-steroid inflammatory drug used in the last 24 hours

Treatment and study plan

Continuous Positive Airway Pressure

Device

continuous positive airway pressure is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people who are able to breathe spontaneously on their own, but need help keeping their airway unobstructed

Polysomnography

Device

Polysomnography measures Apnea-hypopnea index (Minutes)

Classify and identify Obstructive Sleep Apnea Syndrome (OSAS):

  • Apnea-hypopnea index: 5-14.9 olan; mild OSAS
  • Apnea-hypopnea index: 15-29.9: moderate OSAS
  • Apnea-hypopnea index ≥30: severe OSAS measures duration and percentage of time oxygen saturation dropped below 90% the total minutes of sleep

Primary outcomes

  1. Visual Analoge Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

    Mnimum-maximum values: 0-10 Higher scores mean worse outcome for pain scores

  2. Algometer

    Time frame: From enrollment to the end of treatment at 12 weeks

    pain pressure treshold measurements unit: kg/m2 Higher scores mean better outcome

  3. Fibromiyalgia Fatigue Scale Questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    min-max scores:0-72 measures disability Higher scores mean worse outcome

  4. Fibromiyalgia Impact Questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks"

    measures disability level of patients with Fibromyalgia min-max scores: 0-100 Higher scores mean worse outcome

Secondary outcomes

  1. Epworth Sleepness Scale Questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    measures sleep quality min-max scores: 0-24 score between 16-24 on this scale is considered increased daytime sleepiness

  2. Back Depression Inventory

    Time frame: From enrollment to the end of treatment at 12 weeks

    measures depression level min-max values: 0-63 Higher scores mean worse outcome

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study title

The Incidence of Fibromyalgia in Patients with OUAS and the Effect of CPAP Treatment on Fibromiyalgia Symptom Severity

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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