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ClinicalTrials.gov ID

NCT04562519

Lead Sponsor

Cairo UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Nov 9, 2020Actual

Start Date

Jan 2017Actual

Primary Completion Date

Apr 1, 2021Estimated

Completion Date

May 2021Estimated

Official Title

Hyposalivation Response to TENS in HD Patients

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).

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.

• Hemodialysis Complication

• TENS

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Cairo UniversityOTHER

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