Obstructive Sleep Apnea SyndromesNCT07169058
Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea
A study testing Vagus Nerve Fascial Mobilization in people with Obstructive Sleep Apnea Syndromes, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was designed to investigate the effects of fascial mobilization along the course of the vagus nerve on acute physiological parameters in individuals with obstructive sleep apnea syndrome (OSAS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndromes
- What is being tested?
- Vagus Nerve Fascial Mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with moderate to severe obstructive sleep apnea syndrome (OSAS) confirmed by polysomnography (PSG) according to international criteria (AASM - American Academy of Sleep Medicine) with an apnea-hypopnea index (AHI ≥15/hour).
- Patients aged between 18 and 65 years.
- Patients able to comply with PSG procedures and the manual mobilization protocol.
- Patients with stable cardiac and respiratory status.
- Patients without acute exacerbations or decompensated disease.
- Patients who have not received CPAP, BiPAP, oral appliance therapy, or surgical treatment previously, or who discontinued such treatments at least 3 months prior to enrollment.
- Patients not taking medications that directly affect sleep patterns or autonomic nervous system function (e.g., sedatives, hypnotics, anticholinergics).
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patients with uncontrolled hypertension.
- Patients with advanced heart failure, severe arrhythmia, or asthma.
- Patients with coronary artery disease.
- Patients with a history of cerebrovascular disease.
- Patients with chronic obstructive pulmonary disease (COPD).
- Patients with interstitial lung disease.
Show all 18Show fewer
- Patients with epilepsy, Parkinson's disease, or dementia.
- Patients with major depressive disorder or anxiety disorder.
- Patients with a body mass index (BMI) > 40 kg/m².
- Patients with a history of major surgery in the cervical region (e.g., thyroidectomy, cervical disc surgery) or vagus nerve injury.
- Patients with acute infection, skin lesions, or inflammatory disease in the neck/thoracic region.
- Patients currently using CPAP, BiPAP, or oral appliances.
- Patients with narcolepsy, insomnia, or parasomnia.
- Patients with alcohol use or taking sedative/hypnotic medications.
- Patients with night-shift work schedules or irregular sleep patterns.
- Pregnant or breastfeeding women.
- Patients with cognitive impairment preventing adherence to the study protocol.
- Patients with severe musculoskeletal limitations (e.g., in the cervical/thoracic region) that would prevent mobilization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mardin Artuklu University
Mardin, Mardin, 47000
About this study
Official title: The Effect of Fascial Mobilization Along the Course of the Vagus Nerve on Acute Physiological Parameters in Patients With Obstructive Sleep Apnea Syndrome
This randomized controlled trial was designed to investigate the effects of fascial mobilization along the course of the vagus nerve on acute physiological parameters in individuals with obstructive sleep apnea syndrome (OSAS). Patients diagnosed with moderate to severe OSAS by polysomnography at Mardin Training and Research Hospital Sleep Laboratory will be included in the study. Participants will be randomly assigned to mobilization or control groups. In the mobilization group, 16 minutes of manual fascial mobilization will be applied to fascial regions associated with the vagus nerve, starting from the occipitomastoid suture and extending through the cervical, thoracic, and abdominal regions. The control group will rest in the supine position for the same duration. Heart rate, systolic and diastolic blood pressure, and peripheral oxygen saturation (SpO₂) will be recorded before and after the intervention. This study is expected to demonstrate the effectiveness of fascial mobilization as a non-invasive, low-cost, and innovative approach in the treatment of OSAS, contributing to clinical practice.
- Conditions
- Obstructive Sleep Apnea Syndromes
- Being tested
- Vagus Nerve Fascial Mobilization
- Keywords
- Sleep Apnea, Obstructive, Vagus Nerve, Autonomic Nervous System, Fascial Mobilization
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Fascial MobilizationBehavioural
Also called 1
Reference Points of the Body Regions for Mobilization
- Occipito-Mastoid Suture (OM) The occipitomastoid suture is the cranial suture located between the occipital bone and the mastoid part of the temporal bone. The condylus squamosa mastoidea serves as the pivot point. The patient lies in the supine position while the physiotherapist sits at the head of the patient. One hand is placed under the occiput at the suture, while the other hand is placed on the mastoid portion of the temporal bone. The patient's head is turned toward the direction of mobilization, and mobilization is performed using the weight of the head (25). Each application is planned as a single repetition lasting 120 seconds.
- Anterior Cervical Region (Triangle) Topographically, this region is located at the anterior part of the neck, extending along the seven cervical vertebrae (C1-C7). The anterior triangle is bordered superiorly by the lower margin of the mandible, laterally by the anterior median line of the s
| Study group | Role | What they receive |
|---|---|---|
| Vagus Nerve Fascial Mobilization | Experimental | Participants in this group will receive manual fascial mobilization along anatomical regions associated with the vagus nerve, including the occipitomastoid suture, anterior and posterior cervical regions, hyoid, sternum, diaphragm, Trigonum Labbe, and radix mesenteri. Mobilization will be applied for a total of 16 minutes using gentle manual pressure and stretching techniques by a physiotherapist. Heart rate, systolic and diastolic blood pressure, and oxygen saturation will be measured before and after the intervention. Receives: Behavioral: Vagus Nerve Fascial Mobilization |
| Sham Control Group | Sham comparator | Participants in this group will receive a sham procedure. The physiotherapist will place hands on the same anatomical regions for 16 minutes without applying mobilization or therapeutic pressure. No active fascial mobilization will be performed. Heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded before and after the sham procedure. Receives: Behavioral: Vagus Nerve Fascial Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (mmHg)
Systolic blood pressure will be measured non-invasively using a bedside patient monitor. The outcome will assess changes in systolic blood pressure (mmHg) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure.
Measured: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Heart Rate (beats per minute)
Heart rate will be measured using a bedside patient monitor. The outcome will assess the change in beats per minute (bpm) from baseline (before intervention) to post-intervention. The measure will determine the acute effect of fascial mobilization along the vagus nerve compared with sham procedure.
Measured: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Diastolic Blood Pressure (mmHg)
Diastolic blood pressure will be measured non-invasively using a bedside patient monitor. The outcome will assess changes in diastolic blood pressure (mmHg) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure.
Measured: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Peripheral Oxygen Saturation (SpO₂, %)
"Peripheral oxygen saturation will be measured using pulse oximetry integrated into the bedside patient monitor. The outcome will assess changes in SpO₂ (%) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure."
Measured: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Aug 2025
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a randomized controlled trial with two parallel groups. Participants diagnosed with moderate to severe obstructive sleep apnea syndrome will be randomly assigned to either the fascial mobilization group or the control group. The intervention group will receive 16 minutes of manual fascial mobilization along anatomical regions associated with the vagus nerve, while the control group will rest in a supine position for the same duration. The study aims to evaluate acute physiological responses including heart rate, systolic and diastolic blood pressure, and oxygen saturation before and after the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ramazanoglu, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169058
- Sponsor's protocol ID
- 2025/2-11
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision will depend on journal requirements and ethical committee approval
Publications
Delaney JP, Leong KS, Watkins A, Brodie D. The short-term effects of myofascial trigger point massage therapy on cardiac autonomic tone in healthy subjects. J Adv Nurs. 2002 Feb;37(4):364-71. doi: 10.1046/j.1365-2648.2002.02103.x.
PubMed 11872106Austelle CW, Cox SS, Wills KE, Badran BW. Vagus nerve stimulation (VNS): recent advances and future directions. Clin Auton Res. 2024 Dec;34(6):529-547. doi: 10.1007/s10286-024-01065-w. Epub 2024 Oct 4.
PubMed 39363044
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fascial Mobilization Along the Course of the Vagus Nerve on Acute Physiological Parameters in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT07169058
- Acronym / sponsor ID
- 2025/2-11
- Conditions
- Obstructive Sleep Apnea Syndromes
- Keywords
- Sleep Apnea, Obstructive, Vagus Nerve, Autonomic Nervous System, Fascial Mobilization
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial was designed to investigate the effects of fascial mobilization along the course of the vagus nerve on acute physiological parameters in individuals with obstructive sleep apnea syndrome (OSAS). Patients diagnosed with moderate to severe OSAS by polysomnography at Mardin Training and Research Hospital Sleep Laboratory will be included in the study. Participants will be randomly assigned to mobilization or control groups. In the mobilization group, 16 minutes of manual fascial mobilization will be applied to fascial regions associated with the vagus nerve, starting from the occipitomastoid suture and extending through the cervical, thoracic, and abdominal regions. The control group will rest in the supine position for the same duration. Heart rate, systolic and diastolic blood pressure, and peripheral oxygen saturation (SpO₂) will be recorded before and after the intervention. This study is expected to demonstrate the effectiveness of fascial mobilization as a non-invasive, low-cost, and innovative approach in the treatment of OSAS, contributing to clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized controlled trial with two parallel groups. Participants diagnosed with moderate to severe obstructive sleep apnea syndrome will be randomly assigned to either the fascial mobilization group or the control group. The intervention group will receive 16 minutes of manual fascial mobilization along anatomical regions associated with the vagus nerve, while the control group will rest in a supine position for the same duration. The study aims to evaluate acute physiological responses including heart rate, systolic and diastolic blood pressure, and oxygen saturation before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Fascial Mobilization | Experimental | Behavioral: Vagus Nerve Fascial MobilizationParticipants in this group will receive manual fascial mobilization along anatomical regions associated with the vagus nerve, including the occipitomastoid suture, anterior and posterior cervical regions, hyoid, sternum, diaphragm, Trigonum Labbe, and radix mesenteri. Mobilization will be applied for a total of 16 minutes using gentle manual pressure and stretching techniques by a physiotherapist. Heart rate, systolic and diastolic blood pressure, and oxygen saturation will be measured before and after the intervention. |
| Sham Control Group | Sham comparator | Behavioral: Vagus Nerve Fascial MobilizationParticipants in this group will receive a sham procedure. The physiotherapist will place hands on the same anatomical regions for 16 minutes without applying mobilization or therapeutic pressure. No active fascial mobilization will be performed. Heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded before and after the sham procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients diagnosed with moderate to severe obstructive sleep apnea syndrome (OSAS) confirmed by polysomnography (PSG) according to international criteria (AASM - American Academy of Sleep Medicine) with an apnea-hypopnea index (AHI ≥15/hour).
- Patients aged between 18 and 65 years.
- Patients able to comply with PSG procedures and the manual mobilization protocol.
- Patients with stable cardiac and respiratory status.
- Patients without acute exacerbations or decompensated disease.
Key exclusion criteria (18 listed)
- Patients with uncontrolled hypertension.
- Patients with advanced heart failure, severe arrhythmia, or asthma.
- Patients with coronary artery disease.
- Patients with a history of cerebrovascular disease.
- Patients with chronic obstructive pulmonary disease (COPD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve Fascial MobilizationAlso: 1Reference Points of the Body Regions for Mobilization 1. Occipito-Mastoid Suture (OM) The occipitomastoid suture is the cranial suture located between the occipital bone and the mastoid part of the temporal bone. The condylus squamosa mastoidea serves as the pivot point. The patient lies in the supine position while the physiotherapist sits at the head of the patient. One hand is placed under the occiput at the suture, while the other hand is placed on the mastoid portion of the temporal bone. The patient's head is turned toward the direction of mobilization, and mobilization is performed using the weight of the head (25). Each application is planned as a single repetition lasting 120 seconds. 2. Anterior Cervical Region (Triangle) Topographically, this region is located at the anterior part of the neck, extending along the seven cervical vertebrae (C1-C7). The anterior triangle is bordered superiorly by the lower margin of the mandible, laterally by the anterior median line of the s | Behavioural | Sham Control Group, Vagus Nerve Fascial Mobilization |
Primary outcome
Systolic Blood Pressure (mmHg)
Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Systolic blood pressure will be measured non-invasively using a bedside patient monitor. The outcome will assess changes in systolic blood pressure (mmHg) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure.
Heart Rate (beats per minute)
Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Heart rate will be measured using a bedside patient monitor. The outcome will assess the change in beats per minute (bpm) from baseline (before intervention) to post-intervention. The measure will determine the acute effect of fascial mobilization along the vagus nerve compared with sham procedure.
Diastolic Blood Pressure (mmHg)
Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Diastolic blood pressure will be measured non-invasively using a bedside patient monitor. The outcome will assess changes in diastolic blood pressure (mmHg) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure.
Peripheral Oxygen Saturation (SpO₂, %)
Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
"Peripheral oxygen saturation will be measured using pulse oximetry integrated into the bedside patient monitor. The outcome will assess changes in SpO₂ (%) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 11872106Delaney JP, Leong KS, Watkins A, Brodie D. The short-term effects of myofascial trigger point massage therapy on cardiac autonomic tone in healthy subjects. J Adv Nurs. 2002 Feb;37(4):364-71. doi: 10.1046/j.1365-2648.2002.02103.x.
- Results publication: PubMed 39363044Austelle CW, Cox SS, Wills KE, Badran BW. Vagus nerve stimulation (VNS): recent advances and future directions. Clin Auton Res. 2024 Dec;34(6):529-547. doi: 10.1007/s10286-024-01065-w. Epub 2024 Oct 4.
- Individual participant dataSharing planned: Undecided. The decision will depend on journal requirements and ethical committee approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Fascial Mobilization in people with Obstructive Sleep Apnea Syndromes, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (mmHg) (time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169058, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.