Hypersialorrhea (Excessive Salivation)Chew DailyNCT07158359
Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation
A study testing chewing gum mastication in people with Hypersialorrhea (Excessive Salivation) and Psychiatric Disorders, run by Centre Hospitalier de Cadillac.
Trial summary
Psychiatric disorders often require specific treatments, usually involving medications called psychotropic drugs. While effective, these medications can cause significant side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersialorrhea (Excessive Salivation), Psychiatric Disorders
- What is being tested?
- chewing gum mastication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Hospitalized at Cadillac Hospital, either in full inpatient care or at the rehabilitation facility, excluding the UHSA.
- Experiencing iatrogenic hypersalivation induced by psychotropic medications.
- Salivary flow causing functional impairment for the patient, or observed by family members or healthcare providers.
- With or without pharmacological management of hypersalivation.
- Individuals under legal protective measures may be included.
- Provided written informed consent prior to participation.
Who cannot join
- Anatomical/morphological anomaly affecting mastication/swallowing
- Swallowing disorder of organic etiology (e.g., neurological deficit due to stroke, neurodegenerative disease, oropharyngeal surgery, etc.)
- Known risk of aspiration with liquids
- Patient refusal of chewing gum or inability to obtain consent (e.g., non-communicative patients)
- Oral/dental condition preventing mastication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation : a Pilot Study L'Utilisation du Chewing-gum Dans la Prise en Charge de l'hypersialorrhée : Une étude Pilote
Psychiatric disorders often require specific treatments, usually involving medications called psychotropic drugs. While effective, these medications can cause significant side effects. One of the most common is hypersalivation (excess saliva), which can make swallowing difficult and be very uncomfortable in daily life.
Current medication-based solutions are often not very effective and may cause additional side effects. For this reason, we are exploring a different approach: using chewing gum as a form of rehabilitation.
Read more
The goal of this study is to determine whether chewing gum can help reduce excessive saliva. To do this, we will compare two groups: one that will follow a swallowing rehabilitation program including chewing gum, and another that will not.
We hope this simple, non-drug-based approach will improve the management of hypersalivation. More broadly, this research aims to highlight innovative and accessible solutions in psychiatry, showing that alternative strategies-sometimes very simple ones-can also be effective.
Read the detailed description
Introduction Psychiatric disorders necessitate highly specific therapeutic approaches. Psychotropic medications, which are frequently prescribed in these settings, are well known for their substantial burden of adverse drug reactions. Among these, hypersialorrhea (excessive salivation) is a particularly common and disabling side effect, often associated with swallowing disturbances. Current pharmacological alternatives proposed to address this condition remain of limited efficacy and may themselves induce additional adverse effects. In light of these limitations, a rehabilitative, non-pharmacological intervention such as chewing gum mastication may represent a promising strategy.
Objective The primary objective of this pilot study is to assess the effect of chewing gum mastication on hypersialorrhea in patients receiving psychotropic medications.
Methods A randomized controlled trial will be conducted, comparing two groups: an experimental group undergoing a swallowing rehabilitation program incorporating chewing gum mastication, and a control group receiving no chewing-gum-based intervention.
Expected Results This study is expected to provide preliminary evidence supporting the clinical utility of chewing gum mastication as a non-pharmacological approach for the management of hypersialorrhea. Beyond its direct clinical implications, the study aims to promote awareness of innovative, unconventional, yet potentially effective therapeutic strategies in psychiatry, thereby fostering further research in this field.
Keywords Rehabilitation; occupational therapy; psychiatry; pilot study; chewing gum mastication; clinical management; non-pharmacological treatment.
- Being tested
- chewing gum mastication
- Keywords
- Rehabilitation, occupational therapy, pilot study, chewing gum mastication, non-pharmacological treatment
- Medical subject headings
- Sialorrhea, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gum masticationBehavioural
chewing gum mastication
| Study group | Role | What they receive |
|---|---|---|
| Experimental group assigned to a swallowing rehabilitation program involving chewing gum mastication | Experimental | Each participant will receive a rehabilitation session (including chewing gum mastication) three times per week over a four-week period. Each session will last 15 minutes (i.e., 10 minutes of mastication followed by a 5-minute waiting period prior to reassessment). The 10-minute mastication period was determined based on clinical feedback from patients regarding this practice. Rehabilitation sessions will always take place at least 30 minutes after meals.
During each mastication session, the participant will be observed in a quiet room, with a comic book available for distraction. Hypersialorrhea will be assessed three times per session using the DSFS scale: immediately before chewing gum mastication, at the end of the mastication period, and 5 minutes thereafter.
The rehabilitation program will run over four weeks, from Monday to Friday, corresponding to 12 non-consecutive days. The four-week duration was chosen in accordance with standard occupational therapy clinical practice. In Receives: Behavioral: chewing gum mastication |
| Control group | No intervention | For the control group, which will not receive any rehabilitation, the same schedule will be followed. Each participant will be seen three times per week for 15 minutes. During these observation sessions (no intervention, absence of any rehabilitation), hypersialorrhea will be assessed three times using the DSFS scale: immediately before, at the end of the 10-minute period, and 5 minutes thereafter. During these observation sessions, participants will be placed in a quiet room with a comic book available for distraction. The observation period will span four weeks, corresponding to 12 non-consecutive days. In parallel, the healthcare team will be asked to respond three times per week to a single adherence-related question during the scheduled sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary flow measured using the Drooling Severity and Frequency Scale (DSFS) in relation to chewing gum mastication
Measured: 4 weeks
Secondary outcomes (4)
Quality of life, evaluated with the Clinical Global Impression (CGI), was assessed pre- and post-experimental phase
Measured: 4 weeks
Patient adherence to medication will be assessed weekly by the healthcare team using a single dichotomous question: "Did the patient demonstrate opposition to taking their medication related to hypersalivation?"
Measured: 4 weeks
Use of pharmacological agents associated with adverse effects will be monitored through prescription tracking.
Measured: 4 weeks
Tolerance and safety of chewing gum as a therapeutic intervention will be evaluated by the investigative team at each session using two dichotomous questions: "Did you observe any tolerance or safety issues during chewing gum mastication in this session?
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersialorrhea (Excessive Salivation)Studies 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 falls within the field of Research Involving Human Participants. It is classified as Category 2: interventional research involving minimal risk. The study is designed as a prospective, longitudinal investigation.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cadillac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158359
- Sponsor's protocol ID
- 2025-A00525-44
- Other IDs
- IDRCB
- Acronym
- Chew Daily
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation : a Pilot Study L'Utilisation du Chewing-gum Dans la Prise en Charge de l'hypersialorrhée : Une étude Pilote
- ClinicalTrials.gov ID
- NCT07158359
- Acronym / sponsor ID
- Chew Daily / 2025-A00525-44
- Keywords
- Rehabilitation, occupational therapy, pilot study, chewing gum mastication, non-pharmacological treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CadillacUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 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.
Psychiatric disorders often require specific treatments, usually involving medications called psychotropic drugs. While effective, these medications can cause significant side effects. One of the most common is hypersalivation (excess saliva), which can make swallowing difficult and be very uncomfortable in daily life.
Current medication-based solutions are often not very effective and may cause additional side effects. For this reason, we are exploring a different approach: using chewing gum as a form of rehabilitation.
The goal of this study is to determine whether chewing gum can help reduce excessive saliva. To do this, we will compare two groups: one that will follow a swallowing rehabilitation program including chewing gum, and another that will not.
We hope this simple, non-drug-based approach will improve the management of hypersalivation. More broadly, this research aims to highlight innovative and accessible solutions in psychiatry, showing that alternative strategies-sometimes very simple ones-can also be effective.
Detailed description
Introduction Psychiatric disorders necessitate highly specific therapeutic approaches. Psychotropic medications, which are frequently prescribed in these settings, are well known for their substantial burden of adverse drug reactions. Among these, hypersialorrhea (excessive salivation) is a particularly common and disabling side effect, often associated with swallowing disturbances. Current pharmacological alternatives proposed to address this condition remain of limited efficacy and may themselves induce additional adverse effects. In light of these limitations, a rehabilitative, non-pharmacological intervention such as chewing gum mastication may represent a promising strategy.
Objective The primary objective of this pilot study is to assess the effect of chewing gum mastication on hypersialorrhea in patients receiving psychotropic medications.
Methods A randomized controlled trial will be conducted, comparing two groups: an experimental group undergoing a swallowing rehabilitation program incorporating chewing gum mastication, and a control group receiving no chewing-gum-based intervention.
Expected Results This study is expected to provide preliminary evidence supporting the clinical utility of chewing gum mastication as a non-pharmacological approach for the management of hypersialorrhea. Beyond its direct clinical implications, the study aims to promote awareness of innovative, unconventional, yet potentially effective therapeutic strategies in psychiatry, thereby fostering further research in this field.
Keywords Rehabilitation; occupational therapy; psychiatry; pilot study; chewing gum mastication; clinical management; non-pharmacological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study falls within the field of Research Involving Human Participants. It is classified as Category 2: interventional research involving minimal risk. The study is designed as a prospective, longitudinal investigation.
| Arm | Type | Receives |
|---|---|---|
| Experimental group assigned to a swallowing rehabilitation program involving chewing gum mastication | Experimental | Behavioral: chewing gum masticationEach participant will receive a rehabilitation session (including chewing gum mastication) three times per week over a four-week period. Each session will last 15 minutes (i.e., 10 minutes of mastication followed by a 5-minute waiting period prior to reassessment). The 10-minute mastication period was determined based on clinical feedback from patients regarding this practice. Rehabilitation sessions will always take place at least 30 minutes after meals. During each mastication session, the participant will be observed in a quiet room, with a comic book available for distraction. Hypersialorrhea will be assessed three times per session using the DSFS scale: immediately before chewing gum mastication, at the end of the mastication period, and 5 minutes thereafter. The rehabilitation program will run over four weeks, from Monday to Friday, corresponding to 12 non-consecutive days. The four-week duration was chosen in accordance with standard occupational therapy clinical practice. In |
| Control group | No intervention | –For the control group, which will not receive any rehabilitation, the same schedule will be followed. Each participant will be seen three times per week for 15 minutes. During these observation sessions (no intervention, absence of any rehabilitation), hypersialorrhea will be assessed three times using the DSFS scale: immediately before, at the end of the 10-minute period, and 5 minutes thereafter. During these observation sessions, participants will be placed in a quiet room with a comic book available for distraction. The observation period will span four weeks, corresponding to 12 non-consecutive days. In parallel, the healthcare team will be asked to respond three times per week to a single adherence-related question during the scheduled sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 65 years.
- Hospitalized at Cadillac Hospital, either in full inpatient care or at the rehabilitation facility, excluding the UHSA.
- Experiencing iatrogenic hypersalivation induced by psychotropic medications.
- Salivary flow causing functional impairment for the patient, or observed by family members or healthcare providers.
- With or without pharmacological management of hypersalivation.
Key exclusion criteria (5 listed)
- Anatomical/morphological anomaly affecting mastication/swallowing
- Swallowing disorder of organic etiology (e.g., neurological deficit due to stroke, neurodegenerative disease, oropharyngeal surgery, etc.)
- Known risk of aspiration with liquids
- Patient refusal of chewing gum or inability to obtain consent (e.g., non-communicative patients)
- Oral/dental condition preventing mastication
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 |
|---|---|---|
| chewing gum masticationchewing gum mastication | Behavioural | Experimental group assigned to a swallowing rehabilitation program involving chewing gum mastication |
Primary outcome
Salivary flow measured using the Drooling Severity and Frequency Scale (DSFS) in relation to chewing gum mastication
Time frame: 4 weeks
4 secondary outcomes
Quality of life, evaluated with the Clinical Global Impression (CGI), was assessed pre- and post-experimental phase
Time frame: 4 weeks
Patient adherence to medication will be assessed weekly by the healthcare team using a single dichotomous question: "Did the patient demonstrate opposition to taking their medication related to hypersalivation?"
Time frame: 4 weeks
Use of pharmacological agents associated with adverse effects will be monitored through prescription tracking.
Time frame: 4 weeks
Tolerance and safety of chewing gum as a therapeutic intervention will be evaluated by the investigative team at each session using two dichotomous questions: "Did you observe any tolerance or safety issues during chewing gum mastication in this session?
Time frame: 4 weeks
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 5 Sep 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing chewing gum mastication in people with Hypersialorrhea (Excessive Salivation) and Psychiatric Disorders, run by Centre Hospitalier de Cadillac.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Alix AL Lavandier, PhD (+33556765148 ext. +33, alix.lavandier@ch-cadillac.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary flow measured using the Drooling Severity and Frequency Scale (DSFS) in relation to chewing gum mastication (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.