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

December 29, 2022 updated by: Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • City Centre
      • Kırşehir, City Centre, Turkey, 40100
        • Ahi Evran University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Our research will be carried out in patients diagnosed with OSAS after being evaluated in the sleep laboratory of the Kırşehir EAH Department of Chest Diseases. Fibromyalgia screening will be performed on participants who are diagnosed with OSAS and accepted to participate in the study. Patients who were diagnosed 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 will be divided into two groups as FM (control group).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Case group
Patients who meet the 2010 American College of Rheumatology diagnostic criteria and were diagnosed with OSAS in the sleep laboratory will be considered as the case group.
Control group
Patients who did not meet the 2010 American College of Rheumatology diagnostic criteria and were diagnosed with OSAS in the sleep laboratory will be considered as the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale
Time Frame: 0 day (baseline)
"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)
Fibromyalgia Impact Scale
Time Frame: 0 day (baseline)
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)
Beck Anxiety and Depression Inventory.
Time Frame: 0 day (baseline)
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)
visual analog scale
Time Frame: 0 day (baseline)
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)
Algometer.
Time Frame: 0 day (baseline)
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)
Demografic Datas
Time Frame: 0 day (baseline)
Sex, chronic disease, smoking
0 day (baseline)
BMI
Time Frame: 0 day (baseline)
64 / 5.000 Çeviri sonuçları Body mass index will be calculated by measuring height (cm), weight (kg),
0 day (baseline)
Polisomnografi - SLEEP LATENCE
Time Frame: 0 day (baseline)
Sleep latency time will be measured in polysomnography
0 day (baseline)
Polisomnografi -SLEEP ACTIVITY
Time Frame: 0 day (baseline)
Sleep efficiency will be measured during polysomnography
0 day (baseline)
Polisomnografi -REM time
Time Frame: 0 day (baseline)
REM time will be measured in minutes during polysomnography
0 day (baseline)
Polisomnografi -NREM STAGES
Time Frame: 0 day (baseline)
During polysomnography, NREM stages will be measured at 1 min, 2 min, and 3 min.
0 day (baseline)
Polisomnografi - NUMBERS OF APNE
Time Frame: 0 day (baseline)
Numbers of apnea will be recorded in polysomnographic measurements.
0 day (baseline)
Polisomnografi -NUMBER OF HYPOPNEA
Time Frame: 0 day (baseline)
Numbers of hypopnea will be recorded in polysomnographic measurements.
0 day (baseline)
Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.
Time Frame: 0 day (baseline)
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 (AHİ<5), LIGHT OSAS (AHİ 5-15), MEDIUM OSAS (AHİ 15-30), HEAVY OSAS (AHİ 30+ )
0 day (baseline)
Polisomnografi -OXYGEN DESATURATION INDEX
Time Frame: 0 day (baseline)
Minimum oxygen saturation and average oxygen saturation will be measured in polysomnography.
0 day (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirsehir Ahi Evran Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Basak Cigdem Karacay, Asisst Prof, Kirsehir Ahi Evran Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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