Salivary Flow Rate Response to Electrostimulation in HD Patients

November 6, 2020 updated by: Ali Mohamed Ali ismail, Cairo University

Hyposalivation Response to TENS in HD Patients

Xerostomia is a subjective complaint of dry mouth, whereas hyposalivation is an objective decreased of salivary flow. Hyposalivation was reported in 28.8 % of haemodialysis (HD) patients (Bruzda-Zwiech, 2014).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Stimulation of the salivary glands can be induced mechanically (for example, by chewing gum or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers) or by electrostimulation as transcutnaeous electrical nerve stimulation (TENS) (Bossola and Tazza, 2012).

Eighty HD patients (40 diabetics and 40 nondiabetics) will receive 20 minutes of TENS on skin over bilateral parotid gland, 3 times weekly for 3 weeks to investigate the hyposalivation response of diabetic and non diabetic HD patients to TENS.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

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

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity
    • Dokki
      • Giza, Dokki, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo 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

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eighty HD patients (40 diabetics and 40 non diabetics)
  • HD at least from three month
  • saliva flow less than or equal 0.15 millilitre per minute

Exclusion Criteria:

  • pulmonary or cardiac disorders
  • drugs to treat hyposalivation
  • salivary glands inflammation, tumor, and autoimmune diseases.
  • smokers and alcholics

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: diabetic HD group
Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)
Device: TENS
Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)
ACTIVE_COMPARATOR: Nondiabetic goup
Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)
Device: TENS
Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-week response of salivary flow rate
Time Frame: immediately after the last session
the patients will be ordered to spit saliva in a graduated test tube for 5 minutes after the last session (session number 9). To calculate salivary flow rate: saliva volume will be divided on duration of saliva spitting.
immediately after the last session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immediate response of saliva flow
Time Frame: immediately after the first session
the patients will be ordered to spit saliva in a graduated test tube for 5 minutes immediately after the first session . To calculate salivary flow rate: saliva volume will be divided on duration of saliva spitting.
immediately after the first session

Collaborators and Investigators

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

Sponsor

Cairo University

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)

January 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (ACTUAL)

September 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • P.T.REC/012/002679

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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