SleepNCT02593981
Addressing Sleep Problems in Older Adults
A study testing Fruit/Honey drink in people with Sleep, run by Mayo Clinic at 1 site in United States.
Trial summary
As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Fruit/Honey drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2018to Apr 2019
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years old at the time of study registration.
- Individual describes trouble either falling asleep or staying asleep at study entry.
- Willing to participate in all aspects of the study.
- Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.
- Willing to avoid changes to current sleep medications (may use a stable dose of a currently prescribe sleep medication during the first 4 weeks after stating the intervention).
Who cannot join
- Allergic to kiwifruit, cherries, honey, apples, or bananas.
- Hospitalized or living in a care facility at the time of enrollment.
- Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.
- Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.
- Healthcare provider does not think that study candidate has a specific health problem that precludes participation.
- Allergy or intolerance of milk products.
- Women of child bearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Sleep, Perchance to Dream: A Randomized, Placebo-Controlled Study to Test a Fruit/Honey-Based Foodstuff for Sleep Problems in Older Adults
As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals.
The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.
Read the detailed description
This is a randomized, placebo-controlled double-blinded pilot study to explore the use of a fruit/honey drink product for improving sleep in older adults. The purpose of this study is to estimate the effects of a fruit/honey drink using various assessment tools when used as short-term intervention.
This trial proposes to enroll a total of 60 community based older adults. All study patients will be instructed to take the study product every day for 28 days. During which time, study subjects will return weekly to complete study visits for a total of 4 visits.
- Conditions
- Sleep
- Being tested
- Fruit/Honey drink, Placebo
- Keywords
- sleep, fruit, honey, geriatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit/Honey drinkDietary supplement
2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days
PlaceboDietary supplement
2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Fruit/Honey Drink | Active comparator | Fruit/Honey Drink (2 canisters) will be taken orally twice a day. Subjects will consume the drink on days 1 through 28. Receives: Dietary Supplement: Fruit/Honey drink |
| Placebo | Placebo comparator | Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSQI score
Pittsburgh Sleep Quality Index (PSQI):
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startMar 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: Unable to obtain study agent
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593981
- Sponsor's protocol ID
- 15-006031
- Status last verified
- Dec 2018
- First submitted
- 29 Oct 2015
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Sleep, Perchance to Dream: A Randomized, Placebo-Controlled Study to Test a Fruit/Honey-Based Foodstuff for Sleep Problems in Older Adults
- ClinicalTrials.gov ID
- NCT02593981
- Acronym / sponsor ID
- 15-006031
- Conditions
- Sleep
- Keywords
- sleep, fruit, honey, geriatric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain study agent
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 2 Nov 2015 (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.
As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals.
The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.
Detailed description
This is a randomized, placebo-controlled double-blinded pilot study to explore the use of a fruit/honey drink product for improving sleep in older adults. The purpose of this study is to estimate the effects of a fruit/honey drink using various assessment tools when used as short-term intervention.
This trial proposes to enroll a total of 60 community based older adults. All study patients will be instructed to take the study product every day for 28 days. During which time, study subjects will return weekly to complete study visits for a total of 4 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruit/Honey Drink | Active comparator | Dietary Supplement: Fruit/Honey drinkFruit/Honey Drink (2 canisters) will be taken orally twice a day. Subjects will consume the drink on days 1 through 28. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 60 years old at the time of study registration.
- Individual describes trouble either falling asleep or staying asleep at study entry.
- Willing to participate in all aspects of the study.
- Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.
- Willing to avoid changes to current sleep medications (may use a stable dose of a currently prescribe sleep medication during the first 4 weeks after stating the intervention).
Key exclusion criteria (7 listed)
- Allergic to kiwifruit, cherries, honey, apples, or bananas.
- Hospitalized or living in a care facility at the time of enrollment.
- Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.
- Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.
- Healthcare provider does not think that study candidate has a specific health problem that precludes participation.
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 |
|---|---|---|
| Fruit/Honey drink2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days | Dietary supplement | Fruit/Honey Drink |
| Placebo2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days | Dietary supplement | Placebo |
Primary outcome
PSQI score
Time frame: 28 days
Pittsburgh Sleep Quality Index (PSQI):
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Brent Bauer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit/Honey drink in people with Sleep, run by Mayo Clinic 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 5 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: withdrawn, as of the sponsor's last update on 11 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
PSQI score (time frame: 28 days). 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 11 Dec 2018.