The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings

Obstructive Sleep Apnea Clinical Trial

Official title:

The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367167
• Other study ID #: 3
• Status: Completed
• Start date: April 8, 2022
• Est. completion date: November 28, 2022

Study information

• Verified date: December 2022
• Source: Kirsehir Ahi Evran Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fibromyalgia Syndrome (FMS) is a chronic disease that lasts for at least three months and is characterized by various symptoms such as tender points, widespread pain in the musculoskeletal system, sleep disturbance and fatigue. Obstructive sleep apnea (OSAS) is a disease characterized by repeated upper airway obstruction during sleep. Sleep disorders negatively affect the lives of individuals. The prevalence of OSAS is between 1-5% in studies and it is more common in men than in women. Fatigue, anxiety, depression and sleep disturbance are also common in patients with fibromyalgia. Likewise, the presence of symptoms such as musculoskeletal pain in patients with OSAS suggests that these two diseases may be related to each other. We planned this study to show the relationship between OSAS and fibromyalgia (FM).

Description:

Our research will be carried out on patients diagnosed with OSAS after being evaluated in the sleep laboratory of the Research Hospital Department of Chest Diseases. Fibromyalgia screening will be performed on participants who are diagnosed with OSAS and accepted to participate in the study. Patients with FM according to the 2010 American College of Rheumatology diagnostic criteria will be divided into two groups as FM patients (case group) and patients who do not meet these criteria (control group). Sleep laboratory results and demographic data of all patients will be recorded. In addition, anxiety, depression and fatigue levels will be evaluated with scales. Fibromyalgia impact questionnaire will be applied to fibromyalgia patients. Our study is a cross-sectional prospective case-control study. It is not a treatment research, an interventional application will not be made to the patients.

Our hypothesis is that OSAS patients with FMS may have more fatigue, anxiety, depression, lower algometer values, and more severe OSAS findings in polysomnographic data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 28, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1.18-60 years old 2. Diagnosed with OSAS in sleep laboratory examinations 3. Agree to participate in the study

Exclusion Criteria:

1. Pregnancy

2. Neuropsychiatric disease

3. Inflammatory Rheumatic Diseases

4. Morbid obesity

5. Using a device with a previous diagnosis of OSAS

Related Conditions & MeSH terms

• Apnea
• Fibromyalgia
• Myofascial Pain Syndromes
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Turkey	Ahi Evran University	Kirsehir	City Centre

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Koseoglu HI, Inanir A, Kanbay A, Okan S, Demir O, Cecen O, Inanir S. Is There a Link Between Obstructive Sleep Apnea Syndrome and Fibromyalgia Syndrome? Turk Thorac J. 2017 Apr;18(2):40-46. doi: 10.5152/TurkThoracJ.2017.16036. Epub 2017 May 1. — View Citation

Meresh ES, Artin H, Joyce C, Birch S, Daniels D, Owens JH, La Rosa AJ, Rao MS, Halaris A. Obstructive sleep apnea co-morbidity in patients with fibromyalgia: a single-center retrospective analysis and literature review. Open Access Rheumatol. 2019 Apr 29;11:103-109. doi: 10.2147/OARRR.S196576. eCollection 2019. — View Citation

Mutlu P, Zateri C, Zohra A, Ozerdogan O, Mirici AN. Prevalence of obstructive sleep apnea in female patients with fibromyalgia. Saudi Med J. 2020 Jul;41(7):740-745. doi: 10.15537/smj.2020.7.25165. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale	"Fatigue Severity Scale" was used to evaluate the fatigue level of the participants. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. High scores are associated with increased fatigue. Evaluates the effects of fatigue on physical function, motivation, family and social life. Turkish validity and reliability was established.	0 day (baseline)
Primary	Fibromyalgia Impact Scale	The fibromyalgia levels of the participants will be evaluated with the Fibromyalgia Impact Scale. High scores indicate increased disease activity. Consists of 10 questions Maximum score is 80. Turkish validity and reliability was done	0 day (baseline)
Primary	Beck Anxiety and Depression Inventory.	Anxiety and depression levels will be evaluated with the Beck Anxiety and Depression Inventory. Turkish validity and reliability were done.Beck Depression Inventory (BDI) is a 21-item self-assessment scale that measures characteristic attitudes and symptoms of depression. The application takes about 10 minutes to complete. It is designed for people aged 13 and over. High scores report an increased level of depression.Beck anxiety scale This test, which consists of 21 optional questions, is accepted as an internationally valid tool used to measure the severity of anxiety in individuals.Each item marked on the Beck anxiety scale has a score. None is 0 points, mild 1 point, moderate 2 points, and severe 3 points. In this way, these scores are summed after 21 questions are marked. High scores indicate an increased level of anxiety.	0 day (baseline)
Primary	visual analog scale	Pain levels will be evaluated with a visual analog scale. The VAS is a scale that evaluates the severity of pain with the Likert scale. Increased scores indicate severe pain.	0 day (baseline)
Primary	Algometer.	The pain threshold of all patients will be measured with an algometer. Measurement with an algometer is not an invasive measurement method. It shows the patient's pain sensitivity numerically according to the applied pressure.	0 day (baseline)
Primary	Demografic Datas	Sex, chronic disease, smoking	0 day (baseline)
Primary	BMI	64 / 5.000 Çeviri sonuçlari Body mass index will be calculated by measuring height (cm), weight (kg),	0 day (baseline)
Primary	Polisomnografi - SLEEP LATENCE	Sleep latency time will be measured in polysomnography	0 day (baseline)
Primary	Polisomnografi -SLEEP ACTIVITY	Sleep efficiency will be measured during polysomnography	0 day (baseline)
Primary	Polisomnografi -REM time	REM time will be measured in minutes during polysomnography	0 day (baseline)
Primary	Polisomnografi -NREM STAGES	During polysomnography, NREM stages will be measured at 1 min, 2 min, and 3 min.	0 day (baseline)
Primary	Polisomnografi - NUMBERS OF APNE	Numbers of apnea will be recorded in polysomnographic measurements.	0 day (baseline)
Primary	Polisomnografi -NUMBER OF HYPOPNEA	Numbers of hypopnea will be recorded in polysomnographic measurements.	0 day (baseline)
Primary	Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.	Apnea hypopnea index (AHI) will be evaluated as REM, NONREM, Supine, non-supine in polysomnography.According to the AHI level; It will be classified as SIMPLE SNORING (AHI<5), LIGHT OSAS (AHI 5-15), MEDIUM OSAS (AHI 15-30), HEAVY OSAS (AHI 30+ )	0 day (baseline)
Primary	Polisomnografi -OXYGEN DESATURATION INDEX	Minimum oxygen saturation and average oxygen saturation will be measured in polysomnography.	0 day (baseline)