ExperimentalNCT07678515
Salivary Gland Massage and Olfactory Stimulation for Relieving Feeding Difficulty and Triggering Oral Intake Among People With Dementia
A study testing SMART program (Salivary gland massage combined with aromatherapy in people with Experimental and Dementia, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Feeding difficulties are a common issue among individuals with dementia during moderate to advanced stages, particularly those in long-term care (LTC) facilities. Due to severe cognitive and communicative impairment, these residents often have a high dependency on feeding assistance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Experimental, Dementia, RCT
- What is being tested?
- SMART program (Salivary gland massage combined with aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2026to 27 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resided in a long-term care (LTC) facility for more than three months.
- Diagnosed with any type of dementia, with either a Clinical Dementia Rating (CDR) of 2 or higher, a Mini-Mental State Examination (MMSE) score below 20, or a Short Portable Mental Status Questionnaire (SPMSQ) score greater than or equal to 3 errors (indicating moderate to severe impairment).
- A feeding item score of below 5 on the Barthel Index (indicating the participant needs assistance with cutting food, spreading butter, etc., or requires a modified diet or is unable to feed themselves). DOCX
Who cannot join
- Absence of observable expression, behavioral, or response to olfactory stimuli.
- Current use of a nasogastric tube (NG tube) or a percutaneous endoscopic gastrostomy (PEG).
- Diagnosis of hyperphagia or pica.
- Inability to cooperate with the required salivary gland massage.
- Uncontrolled epilepsy, severe or unstable cardiovascular disease, severe asthma, severe chronic obstructive pulmonary disease (COPD), or gastrointestinal bleeding.
- Known allergy to essential oils.
- Undergone surgery related to oral, tongue, or thyroid cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SMART-program：Dual Sensory-Stimulation for Relieving Feeding Difficulty and Triggering Oral Intake Among People With Dementia
Feeding difficulties are a common issue among individuals with dementia during moderate to advanced stages, particularly those in long-term care (LTC) facilities. Due to severe cognitive and communicative impairment, these residents often have a high dependency on feeding assistance. Consequently, caregivers manage not only refusal to eat and prolonged mealtimes but also the resulting nutritional problems among these patients. The eating process includes the anticipatory phase, during which food is identified via sensory triggers, thereby stimulating saliva secretion. This process facilitates bolus formation and ensures a smooth transition to the swallowing phase. Accordingly, this study aims to investigate the efficacy of a dual-sensory intervention, combining salivary gland massage and olfactory stimulation, in improving feeding difficulties and food intake among individuals with moderate-to-severe dementia.
This study will employ a randomized controlled trial (RCT) design. The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days. Simultaneously, baseline characteristics, including sociodemographic data, health status, and oral moisture, will be collected. Data for the 'Dementia Mealtime Nonverbal Cues' and two-meal intake will be monitored daily on weekdays for two weeks; all other variables will be assessed once. During the intervention period, the experimental procedure will be performed twice daily, prior to lunch and dinner. The control group will receive only a palm massage prior to meals. Throughout the intervention, participants will be assessed for "The Dementia Mealtime Nonverbal Cues" and oral intake during lunch and dinner every weekday. Additionally, oral moisture will be evaluated once weekly (T1-T4). Data will be analyzed using Linear Mixed Models (LMM) to examine the differences and longitudinal changes in outcome measures between the two groups. The findings of this study will contribute to the establishment of a safe, feasible, and culturally appropriate feeding care model for institutionalized individuals with dementia.
- Conditions
- Experimental, Dementia, RCT, Dry Mouth, Aromatherapy, Feeding Difficulty
- Being tested
- SMART program (Salivary gland massage combined with aromatherapy
- Keywords
- Dementia, Feeding Difficulty, Dual sensory stimulation
- Medical subject headings
- Dementia, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART program (Salivary gland massage combined with aromatherapyOther
The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control group will receive a placebo intervention consisting of a hand massage, accompanied by general greetings and caring interactions, in their daily activity area. This will be conducted before lunch and dinner for four consecutive weeks on weekdays only. To minimize confounding effects, participants will be restricted from exposure to any olfactory or other extraneous sensory stimuli during this 30-minute pre-meal period. |
| Experimental Group | Experimental | Participants in the experimental group will receive a dual-sensory intervention before lunch and dinner for four consecutive weeks (weekdays only). This consists of a 2-minute salivary gland massage combined with 30 minutes of olfactory stimulation, using 100% lemon essential oil dispersed via a waterless ultrasonic nebulizer. Receives: Other: SMART program (Salivary gland massage combined with aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia Feeding Difficulty Cues
Feeding difficulty is assessed using the unabbreviated scale title: Dementia Mealtime Nonverbal Cues checklist. This adapted checklist consists of 21 items categorized into negative behaviors (chewing/swallowing difficulty and resistive behaviors; 16 items) and positive/neutral behaviors (5 items). Assuming each item is scored as Yes=1 and No=0, the minimum score is 0 and the maximum is 16 for negative behaviors, where higher scores indicate worse feeding difficulties. For positive behaviors, the score ranges from 0 to 5, where higher scores indicate better feeding performance.
Measured: Every lunch and dinner from baseline up to 6 weeks
Secondary outcomes (4)
Oral Intake
Dietary intake at lunch and dinner will be determined using the plate waste method. Food consumption will be quantitatively assessed by measuring and recording food weights in grams (g) to one decimal place before and after meals using the same electronic weighing scale throughout the study to ensure measurement consistency.
Measured: Every lunch and dinner from baseline up to 6 weeks
Duration
Feeding duration is measured continuously using a timer, from the moment the first bite of food is offered until the meal is completed or terminated. The measurement value is recorded precisely in minutes and seconds (analyzed as total seconds). The minimum value is 0 seconds, with no strict maximum limit. A higher value (longer duration) indicates worse feeding efficiency and greater feeding difficulty.
Measured: Every lunch and dinner from baseline up to 6 weeks
Oral moisture
Oral moisture is evaluated using the Mucus® device. The measurement values range from a minimum of 0.0 to a maximum of 99.9. Higher scores indicate better outcomes (normal oral humidity is defined as ≥ 29.6, while ≤ 27.9 indicates dry mouth.
Measured: Once weekly from baseline up to 6 weeks
Body weight
Body weight is measured using a standardized weighing scale, with values recorded in kilograms (kg). To ensure consistency, measurements will be taken at a unified time each month across all participating facilities. The theoretical minimum value is >0 kg, with no strict maximum limit. Because unintentional weight loss is a common complication of feeding difficulties in dementia, weight maintenance or a higher value (weight gain) generally indicates a better nutritional outcome.
Measured: Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start16 Mar 2026
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExperimentalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Ying Li, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678515
- Sponsor's protocol ID
- A-ER-114-511
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART-program：Dual Sensory-Stimulation for Relieving Feeding Difficulty and Triggering Oral Intake Among People With Dementia
- ClinicalTrials.gov ID
- NCT07678515
- Acronym / sponsor ID
- A-ER-114-511
- Conditions
- Experimental, Dementia, RCT, Dry Mouth, Aromatherapy, Feeding Difficulty
- Keywords
- Dementia, Feeding Difficulty, Dual sensory stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Jun 2026 (estimated)
- First posted
- 1 Jul 2026 (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.
Feeding difficulties are a common issue among individuals with dementia during moderate to advanced stages, particularly those in long-term care (LTC) facilities. Due to severe cognitive and communicative impairment, these residents often have a high dependency on feeding assistance. Consequently, caregivers manage not only refusal to eat and prolonged mealtimes but also the resulting nutritional problems among these patients. The eating process includes the anticipatory phase, during which food is identified via sensory triggers, thereby stimulating saliva secretion. This process facilitates bolus formation and ensures a smooth transition to the swallowing phase. Accordingly, this study aims to investigate the efficacy of a dual-sensory intervention, combining salivary gland massage and olfactory stimulation, in improving feeding difficulties and food intake among individuals with moderate-to-severe dementia.
This study will employ a randomized controlled trial (RCT) design. The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days. Simultaneously, baseline characteristics, including sociodemographic data, health status, and oral moisture, will be collected. Data for the 'Dementia Mealtime Nonverbal Cues' and two-meal intake will be monitored daily on weekdays for two weeks; all other variables will be assessed once. During the intervention period, the experimental procedure will be performed twice daily, prior to lunch and dinner. The control group will receive only a palm massage prior to meals. Throughout the intervention, participants will be assessed for "The Dementia Mealtime Nonverbal Cues" and oral intake during lunch and dinner every weekday. Additionally, oral moisture will be evaluated once weekly (T1-T4). Data will be analyzed using Linear Mixed Models (LMM) to examine the differences and longitudinal changes in outcome measures between the two groups. The findings of this study will contribute to the establishment of a safe, feasible, and culturally appropriate feeding care model for institutionalized individuals with dementia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group will receive a placebo intervention consisting of a hand massage, accompanied by general greetings and caring interactions, in their daily activity area. This will be conducted before lunch and dinner for four consecutive weeks on weekdays only. To minimize confounding effects, participants will be restricted from exposure to any olfactory or other extraneous sensory stimuli during this 30-minute pre-meal period. |
| Experimental Group | Experimental | Other: SMART program (Salivary gland massage combined with aromatherapyParticipants in the experimental group will receive a dual-sensory intervention before lunch and dinner for four consecutive weeks (weekdays only). This consists of a 2-minute salivary gland massage combined with 30 minutes of olfactory stimulation, using 100% lemon essential oil dispersed via a waterless ultrasonic nebulizer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Resided in a long-term care (LTC) facility for more than three months.
- Diagnosed with any type of dementia, with either a Clinical Dementia Rating (CDR) of 2 or higher, a Mini-Mental State Examination (MMSE) score below 20, or a Short Portable Mental Status Questionnaire (SPMSQ) score greater than or equal to 3 errors (indicating moderate to severe impairment).
- A feeding item score of below 5 on the Barthel Index (indicating the participant needs assistance with cutting food, spreading butter, etc., or requires a modified diet or is unable to feed themselves). DOCX
Key exclusion criteria (7 listed)
- Absence of observable expression, behavioral, or response to olfactory stimuli.
- Current use of a nasogastric tube (NG tube) or a percutaneous endoscopic gastrostomy (PEG).
- Diagnosis of hyperphagia or pica.
- Inability to cooperate with the required salivary gland massage.
- Uncontrolled epilepsy, severe or unstable cardiovascular disease, severe asthma, severe chronic obstructive pulmonary disease (COPD), or gastrointestinal bleeding.
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 |
|---|---|---|
| SMART program (Salivary gland massage combined with aromatherapyThe experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days. | Other | Experimental Group |
Primary outcome
Dementia Feeding Difficulty Cues
Time frame: Every lunch and dinner from baseline up to 6 weeks
Feeding difficulty is assessed using the unabbreviated scale title: Dementia Mealtime Nonverbal Cues checklist. This adapted checklist consists of 21 items categorized into negative behaviors (chewing/swallowing difficulty and resistive behaviors; 16 items) and positive/neutral behaviors (5 items). Assuming each item is scored as Yes=1 and No=0, the minimum score is 0 and the maximum is 16 for negative behaviors, where higher scores indicate worse feeding difficulties. For positive behaviors, the score ranges from 0 to 5, where higher scores indicate better feeding performance.
4 secondary outcomes
Oral Intake
Time frame: Every lunch and dinner from baseline up to 6 weeks
Duration
Time frame: Every lunch and dinner from baseline up to 6 weeks
Oral moisture
Time frame: Once weekly from baseline up to 6 weeks
Body weight
Time frame: Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention)
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 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART program (Salivary gland massage combined with aromatherapy in people with Experimental and Dementia, run by National Cheng Kung University at 1 site in Taiwan.
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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia Feeding Difficulty Cues (time frame: Every lunch and dinner from baseline up to 6 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 1 Jul 2026.