Obstructive Sleep Apnea Syndrome and Fibromiyalgia

NCT06595771 | Completed

• 1 other identifier: FSMEAH-KAEK 2018/37
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

-------------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

Conditions

Fibromyalgia, Primary

Keywords

obstructive sleep apnea

Outcome Measures

Primary Outcomes (4)

• Visual Analoge Scale

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

  From enrollment to the end of treatment at 12 weeks

• Algometer

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

  From enrollment to the end of treatment at 12 weeks

• Fibromiyalgia Fatigue Scale Questionnaire

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

  From enrollment to the end of treatment at 12 weeks

• Fibromiyalgia Impact Questionnaire

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

  From enrollment to the end of treatment at 12 weeks"

Secondary Outcomes (2)

• Epworth Sleepness Scale Questionnaire

  From enrollment to the end of treatment at 12 weeks

• Back Depression Inventory

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

225 patients with obstructive sleep apnea syndrome

Patients with obstructive sleep apnea syndrome recieved CPAP therapy

Device: continuous positive airway pressure; Device: Polysomnography

Interventions

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

225 patients with obstructive sleep apnea syndrome

Polysomnography DEVICE

Polysomnography measures Apnea-hypopnea index (Minutes) Classify and identify Obstructive Sleep Apnea Syndrome (OSAS): 1. Apnea-hypopnea index: 5-14.9 olan; mild OSAS 2. Apnea-hypopnea index: 15-29.9: moderate OSAS 3. Apnea-hypopnea index ≥30: severe OSAS measures duration and percentage of time oxygen saturation dropped below 90% the total minutes of sleep

225 patients with obstructive sleep apnea syndrome

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Polysomnography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nilgün Mesci, assoc prof

  Haydarpaşa Numune education and research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: September 19, 2024

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)