NCT04562519

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

January 1, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

4.2 years

First QC Date

September 18, 2020

Last Update Submit

November 6, 2020

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

  • 3-week response of salivary flow rate

    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 Outcomes (1)

  • immediate response of saliva flow

    immediately after the first session

Study Arms (2)

diabetic HD group

EXPERIMENTAL

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

Nondiabetic goup

ACTIVE COMPARATOR

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

Interventions

TENSDEVICE

Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)

Nondiabetic goupdiabetic HD group

Eligibility Criteria

Age30 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 24, 2020

Study Start

January 1, 2017

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

EG(2)