Pneumonia, AspirationPhase 3NCT00000362
Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
A Phase 3 study testing Chin-down position and Thickened liquid administration in people with Pneumonia, Aspiration, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Pneumonia, Aspiration
- What is being tested?
- Chin-down position and Thickened liquid administration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows.
Who cannot join
- Have smoked more than a pack of cigarettes per day in the last year.
- Drink more than 3 alcoholic beverages per day on a regular basis.
- Have had any head and neck cancer treatment.
- Have any head and neck anatomic deformities.
- Have a history of 20 years or longer of insulin-dependent diabetes.
- Have other exclusionary neurologic diagnoses.
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- Have had pneumonia within 6 weeks of screening.
- Currently have a nasogastric tube.
- Currently have a tracheotomy.
- Are a resident in non-participating nursing home or assisted living environment.
- Live alone.
- Have no regular care provider present at meals.
- Have no Speech-Language Pathologist to provide a 3-month follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin at Madison & multiple other U.S. locations
Madison, Wisconsin
About this study
The purpose of this study is to determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Liquid aspiration is the most common type of aspiration in older populations, especially those suffering from debilitation, dementia, and depression. Pneumonia may develop as a consequence of aspiration and is the fifth leading cause of death in the US among persons age 65 years and over. Current treatment involves either use of chin-down position with swallowing or use of thickened liquids in the diet, without any clear evidence supporting the use of one treatment over the other. This is a Phase III inpatient and/or outpatient study in which all participants will be randomly assigned to either the chin-down position or the thickened liquid treatment group based on swallowing function during a modified barium swallow. This study is scheduled to recruit patients for a three-year period; participation by each individual patient spans no more than three months after entry.
- Conditions
- Pneumonia, Aspiration
- Being tested
- Chin-down position, Thickened liquid administration
- Keywords
- Deglutition Disorders, Dementia, Parkinson Disease, Pneumonia, Aspiration
- Medical subject headings
- Pneumonia, Aspiration, Deglutition Disorders, Dementia, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chin-down positionBehavioural
Thickened liquid administrationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, AspirationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Joanne Robbins, Study chairDr. Jeri Logemann, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000362
- Sponsor's protocol ID
- NIDCD-1159
- Other IDs
- Protocol 201, U01DC003206
- Status last verified
- Apr 2006
- First submitted
- 2 Nov 1999
- Last updated
- 24 Apr 2006
- Results posted
- No
Publications
Robbins J, Gensler G, Hind J, Logemann JA, Lindblad AS, Brandt D, Baum H, Lilienfeld D, Kosek S, Lundy D, Dikeman K, Kazandjian M, Gramigna GD, McGarvey-Toler S, Miller Gardner PJ. Comparison of 2 interventions for liquid aspiration on pneumonia incidence: a randomized trial. Ann Intern Med. 2008 Apr 1;148(7):509-18. doi: 10.7326/0003-4819-148-7-200804010-00007.
PubMed 18378947
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
- ClinicalTrials.gov ID
- NCT00000362
- Acronym / sponsor ID
- NIDCD-1159
- Conditions
- Pneumonia, Aspiration
- Keywords
- Deglutition Disorders, Dementia, Parkinson Disease, Pneumonia, Aspiration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 600 participants
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study completion
- Jan 2006
- First posted
- 3 Nov 1999 (estimated)
- 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.
The purpose of this study is to determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Liquid aspiration is the most common type of aspiration in older populations, especially those suffering from debilitation, dementia, and depression. Pneumonia may develop as a consequence of aspiration and is the fifth leading cause of death in the US among persons age 65 years and over. Current treatment involves either use of chin-down position with swallowing or use of thickened liquids in the diet, without any clear evidence supporting the use of one treatment over the other. This is a Phase III inpatient and/or outpatient study in which all participants will be randomly assigned to either the chin-down position or the thickened liquid treatment group based on swallowing function during a modified barium swallow. This study is scheduled to recruit patients for a three-year period; participation by each individual patient spans no more than three months after entry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows.
Key exclusion criteria (13 listed)
- Have smoked more than a pack of cigarettes per day in the last year.
- Drink more than 3 alcoholic beverages per day on a regular basis.
- Have had any head and neck cancer treatment.
- Have any head and neck anatomic deformities.
- Have a history of 20 years or longer of insulin-dependent diabetes.
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 |
|---|---|---|
| Chin-down position | Behavioural | – |
| Thickened liquid administration | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2006.
- Derived from this study: PubMed 18378947Robbins J, Gensler G, Hind J, Logemann JA, Lindblad AS, Brandt D, Baum H, Lilienfeld D, Kosek S, Lundy D, Dikeman K, Kazandjian M, Gramigna GD, McGarvey-Toler S, Miller Gardner PJ. Comparison of 2 interventions for liquid aspiration on pneumonia incidence: a randomized trial. Ann Intern Med. 2008 Apr 1;148(7):509-18. doi: 10.7326/0003-4819-148-7-200804010-00007.
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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. This study is not recruiting at the moment.
Dr. Joanne Robbins study chair
Dr. Jeri Logemann principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chin-down position and Thickened liquid administration in people with Pneumonia, Aspiration, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
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 1 inclusion and 13 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: stopped early, as of the sponsor's last update on 24 Apr 2006. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000362, which also lists 1 linked publication.
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 24 Apr 2006.