Sphenopalatine Ganglion Stimulation for Ocular and Oral Dryness

NCT05187533 | Completed

• 1 other identifier: IOBA-2021-23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dry Eye Disease (DED) is a multifactorial pathology characterized by inflammation of the lacrimal functional unit that develops in ocular surface pathology, severely affecting patients quality of life. The core of the treatment relies at present in antinflammatory topical therapies, which are still scarce. The investigators hypothesize that osteopathy-based techniques may help these patients by influencing the central involvement regarding parasympathetic innervation of tear and saliva-secreting glands. The aim of this osteopathic treatment protocol is to release the involved structures in the tear-secreting system innervation, such as the sphenopalatine ganglion. In addition, this ganglion innervates the minor salivary glands, therefore it is intended to help patients suffering from xerostomia. The hypothesis then is that a systemic protocol treatment can help balance both parts of the vegetative nervous system (sympathetic and parasympathetic) with the objective of increasing the secretion of tear and saliva in patients with ocular and oral dryness (DED and xerostomia, respectively), thus improving their clinical situation. This osteopathic protocol does not have the potential to cause adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.

Conditions

Dry Eye Disease; Xerostomia

Keywords

dry eye disease; dryness; osteopathy; Keratoconjunctivitis sicca; Saliva cytokines; Saliva-producing glands; Sjögren´s syndrome; Sphenopalatine ganglion; Tear-producing glands; Tear cytokines; Tear film; Xerostomia

Outcome Measures

Primary Outcomes (14)

• Ocular Surface Disease Index (OSDI)

  Score value 0-48, where higher score means a worse outcome.

  6 Weeks

• Ocular Surface Disease Index (OSDI)

  Score value 0-48, where higher score means a worse outcome.

  18 Weeks

• Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)

  Score value 0-28, where higher score means a worse outcome

  6 Weeks

• Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)

  Score value 0-28, where higher score means a worse outcome

  18 Weeks

• Visual analogue Scale (VAS)

  Unique measurements 0-10, where higher score means a worse outcome

  6 Weeks

• Visual analogue Scale (VAS)

  Unique measurements 0-10, where higher score means a worse outcome

  18 Weeks

• Change in Dry Eye Symptoms Questionnaire (CDES-Q)

  First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.

  6 Weeks

• Change in Dry Eye Symptoms Questionnaire (CDES-Q)

  First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.

  18 Weeks

• Statistically significant amelioration in oral symptoms

  Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.

  6 Weeks

• Statistically significant amelioration in oral symptoms

  Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.

  18 Weeks

• Statistically significant improvement in tear secretion

  Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.

  6 Weeks

• Statistically significant improvement in tear secretion

  Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.

  18 Weeks

• Statistically significant improvement in salivary discharge

  Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.

  6 Weeks

• Statistically significant improvement in salivary discharge

  Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.

  18 Weeks

Secondary Outcomes (8)

• Decrease in tear collection time

  18 Weeks

• Increased salivary flow rate

  18 Weeks

• Lipiflow interferometry - lipid layer thickness

  18 Weeks

• Lipiflow interferometry - incomplete blink rate

  18 Weeks

• Lipiflow interferometry - c-factor

  18 Weeks

Study Arms (3)

Mild dry eye disease

OTHER

Osteopathic protocol of sphenopalatine ganglion stimulation

Other: Osteopathic protocol of Sphenopalatine Ganglion Stimulation

Moderate dry eye disease

OTHER

Osteopathic protocol of sphenopalatine ganglion stimulation

Other: Osteopathic protocol of Sphenopalatine Ganglion Stimulation

Severe dry eye disease

OTHER

Osteopathic protocol of sphenopalatine ganglion stimulation

Other: Osteopathic protocol of Sphenopalatine Ganglion Stimulation

Interventions

Osteopathic protocol of Sphenopalatine Ganglion Stimulation OTHER

Sphenopalatine Ganglion Stimulation to improve lacrimal and salivary gland secretion to improve ocular and oral dryness

Mild dry eye disease; Moderate dry eye disease; Severe dry eye disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old.
• Patients diagnosed with Dry eye disease (DED) and suffering symptoms of ocular and oral dryness for at least 6 months.
• "Dry eye" symptoms must have a score of \> 2 (0-4 range) in mSIDEQ questionnaire.
• Schirmer I test, without topical anesthesia, must have an initial value of ≥ 1 mm and \<10 mm.
• Not included in any other clinical pharmacological trial or study (medical devices are excluded) in the last 3 months.
• Signed informed consent and ability to complete all study visits.

You may not qualify if:

• Irreversible anatomical alteration of the lacrimal glands (watery, sebaceous or mucinic) or salivary, surgeries or by healing processes that affect eyelids and/or conjunctiva.
• Alteration in the autonomic nervous system.
• Another active ocular surface disease different from that caused by DED.
• Oral diseases, inflammations or acute injuries in the mouth (trauma, surgical intervention, etc.) in the last month or healing processes of the oral mucosa.
• Use of cyclosporine or topical tacrolimus started within \< 3 months and/or steroids or blood derivatives started within \< 1 month and that will not be maintained during the study.
• Patients may be using any other medication, topical or systemic, unless the dose are the same for the duration of the study.
• Patients may be using artificial tears, moisturizers in general or blood derivatives, unless the dose was the same in the last month and has to be maintained at the same dose for the duration of the study.
• To have had any "in-office" method to manage DED or Meibomian gland dysfunction (pulsed light, thermal massages, etc.) in the last 6 months.
• Occlusion of the lacrimal puncta in the last month.
• Local (in cranial sphere) or general anesthesia in the last 3 months.

Sponsors & Collaborators

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: lead

Study Sites (1)

IOBA

Valladolid, Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Xerostomia; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: January 12, 2022
• Study Start: January 15, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)