NCT07743892

Brief Summary

Obstructive Sleep Apnea Syndrome (OSAS) is a chronic disease characterized by intermittent hypoxia and sleep fragmentation resulting from recurrent upper airway obstructions. The physiological and neurocognitive changes caused by the disease can affect how individuals perceive and interpret bodily sensations. Although body awareness plays a significant role in the perception and management of symptoms, its relationship with clinical parameters in individuals with OSAS has not been sufficiently investigated. Therefore, the aim of our study is to examine the relationship between body awareness and respiratory function, disease severity, fatigue, shortness of breath, and sleep quality in OSAS patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
May 2026Jun 2027

Study Start

First participant enrolled

May 21, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 28, 2026

Last Update Submit

July 31, 2026

Conditions

Outcome Measures

Primary Outcomes (10)

  • Body awareness

    The Body Awareness Questionnaire (BAQ) will be used to assess individuals' body awareness. The scale score ranges from 18 to 26, with higher scores indicating higher awareness.

    Baseline

  • Dyspnea

    Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.

    Baseline

  • Disease severity

    The evaluation will be based on the Apnea/Hypopnea index measured by polysomnography. An Apnea-Hypopnea Index \>5 indicates Obstructive Sleep Apnea Syndrome.

    Baseline

  • Fatigue severity

    Fatigue will be assessed using the Fatigue Severity Scale. A score of 36 or higher indicates severe fatigue.

    Baseline

  • Sleep quality

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PUKI). The total score ranges from 0 to 21, and a score above 5 indicates poor sleep quality.

    Baseline

  • Pulmonary function (Forced vital capacity (FVC)

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.

    Baseline

  • Pulmonary function (Forced expiratory volume in the first second (FEV1)

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.

    Baseline

  • Pulmonary function (FEV1 / FVC)

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.

    Baseline

  • Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.

    Baseline

  • Pulmonary function (Peak flow rate (PEF))

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.

    Baseline

Study Arms (1)

Obstructive Sleep Apnea Syndrome Group

Patients diagnosed with Obstructive Sleep Apnea Syndrome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with obstructive sleep apnea syndrome

You may qualify if:

  • Receiving a diagnosis of OSA after polysomnography,
  • Having an Apnea-Hypopnea Index ≥5 for OSA,
  • Volunteering to participate in the study.

You may not qualify if:

  • Having severe orthopedic, neurological, or cardiac diseases,
  • Having a diagnosed lung disease,
  • Having a previous or current history of psychiatric or neurological disorders,
  • Not voluntarily participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük Training and Research Hospital

Karabük, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Musa Güneş, PhD

    Karabuk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 4, 2026

Study Start

May 21, 2026

Primary Completion (Estimated)

May 21, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations