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Clinical Trials/NCT06536894
NCT06536894
Not yet recruiting
Not Applicable

The Effect of the Presence Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome

Kirsehir Ahi Evran Universitesi0 sites60 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia Syndrome
Sponsor
Kirsehir Ahi Evran Universitesi
Enrollment
60
Primary Endpoint
Polisomnografi -SLEEP ACTIVITY
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Obstructive type sleep apnea syndrome is a clinical condition characterized by apnea, hypopnea and oxygen desaturation due to narrowing of the upper airway during sleep. Obesity is considered a major predisposing factor for OSAS. In addition, various recent studies have reported that various anthropometric measurements such as neck circumference, waist circumference, hip circumference, waist-hip ratio, neck-waist circumference ratio change (increase) in OSAS patients.

Detailed Description

Fibromyalgia is a common health problem that is characterized by pain in various parts of the body and is very difficult to diagnose and treat. It affects 2-4% of the population and is more common in women. The presence of OSAS in fibromyalgia patients is more common than in the normal population. There are also common additional symptoms such as excessive daytime sleepiness and delayed sleep latency. Although it has been reported that the presence of OSAS is more common in fibromyalgia patients, there is no study on the presence of anthropometric measurements, especially neck circumference, that are accepted in OSAS. The aim of this study is to compare the anthropometric and ultrasonographic measurements of female OSAS patients with and without fibromyalgia.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
February 1, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Kirsehir Ahi Evran Universitesi
Responsible Party
Principal Investigator
Principal Investigator

Basak Cigdem Karacay

Assosc Prof

Kirsehir Ahi Evran Universitesi

Eligibility Criteria

Inclusion Criteria

  • Between 18-65 years old
  • Being diagnosed with fibromyalgia and having applied to the sleep disorders outpatient clinic or being followed up with the diagnosis of OSAS in the sleep disorders outpatient clinic.
  • Agree to participate in the study

Exclusion Criteria

  • Patients under 18 years of age
  • Male patients
  • Not agreeing to participate in the study
  • Neurological diseases that may cause OSAS such as stroke, Parkinson's disease, multiple sclerosis
  • Rheumatological, oncological and hematological diseases
  • Central type obstructive sleep apnea syndrome
  • Thyroid pathology that affects neck circumference measurement

Outcomes

Primary Outcomes

Polisomnografi -SLEEP ACTIVITY

Time Frame: Day 0 ( Baseline)

Sleep efficiency will be measured during polysomnography

Polisomnografi-REM

Time Frame: Day 0 ( Baseline)

REM times will be evaluated in polysomnography

submental ultrasonography

Time Frame: Day 0 ( Baseline)

All patients will undergo submental ultrasonography to measure tongue base thickness and lateral pharyngeal wall thickness.

Polisomnografi -NREM STAGES

Time Frame: Day 0 ( Baseline)

During polysomnography, NREM stages will be measured at 1 min, 2 min, and 3 min.

Polisomnografi -NUMBER OF HYPOPNEA

Time Frame: Day 0 ( Baseline)

Numbers of hypopnea will be recorded in polysomnographic measurements

Polisomnografi-NonREM

Time Frame: Day 0 ( Baseline)

NonREM times will be evaluated in polysomnography

Polisomnografi- SLEEP LATENCE

Time Frame: Day 0 ( Baseline)

Sleep latency time will be measured in polysomnography

Polisomnografi -REM time

Time Frame: Day 0 ( Baseline)

REM time will be measured in minutes during polysomnography

Polisomnografi - NUMBERS OF APNE

Time Frame: Day 0 ( Baseline)

Numbers of apnea will be recorded in polysomnographic measurements.

Polisomnografi -Apnea hypopnea index (AHI) in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.

Time Frame: Day 0 ( Baseline)

Apnea hypopnea index (AHI) will be evaluated 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+ )

Anthropometric Measurements

Time Frame: Day 0 ( Baseline)

Anthropometric measurements will be taken for all patients. These measurements include neck circumference, waist circumference, hip circumference, and with these data, waist-hip ratio and neck-waist circumference ratio will be calculated. Measurements will be made with a tape measure and with patient consent.

Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.

Time Frame: Day 0 ( 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+ )

Polisomnografi -OXYGEN DESATURATION INDEX

Time Frame: Day 0 ( Baseline)

Minimum oxygen saturation and average oxygen saturation will be measured in polysomnography.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index(Day 0 ( Baseline))
  • Fibromyalgia Impact Scale(Day 0 ( Baseline))

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