FrailtyPhase 1NCT05968820
Sleep Health Enhancement in Older Adults to Address Frailty
A Phase 1 study testing Sleep Health Enhancement Intervention in people with Frailty, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Sleep Health Enhancement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 30 Aug 2024
- Phase
- Phase 1
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥65 years old
- ≤ 7 on the RU-SATED self-report questionnaire
- MMSE ≥25 and AD8 <3
Who cannot join
- Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- >3 on the STOP BANG indicating increased risk of sleep apnea
- Evidence of restless legs syndrome on RLS-Diagnosis Index
- Evidence of circadian rhythm sleep-wake disorder
- Evidence of parasomnia
- Regular use (>2x/week) of prescription or over-the-counter medications to improve sleep
Show all 13Show fewer
- Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety
- Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-V criteria
- History of nervous system disorder such as stroke or Parkinson's disease
- Severe mental illness such as schizophrenia or bipolar disorder
- Current or history (within 5 years) of shift work including hours of midnight-4am
- Is currently receiving a behavioral sleep health intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, 66160
About this study
Official title: Tailoring a Sleep Health Enhancement Intervention for Older Adults to Address Frailty
The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. In the treatment development stage, we will recruit n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report questionnaire) to assess acceptability and tailor the sleep health enhancement intervention for older adults. In the pilot study stage to assess preliminary efficacy of the tailored sleep health enhancement intervention, n=30 older adults with poor sleep health will be randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement intervention or to a wait-list control condition. Participants will wear wrist-worn actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and reassessments.
- Conditions
- Frailty
- Being tested
- Sleep Health Enhancement Intervention
- Keywords
- Sleep Health, Older Adults
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Health Enhancement InterventionBehavioural
The program is based on principles from CBT-I (time in bed restriction, stimulus control, relaxation techniques, sleep education) and includes behavioral strategies to entrain circadian rhythm, strengthen sleep homeostasis, reduce hyperarousal, and sleep hygiene techniques. Self-Determination Theory (SDT) and Social Cognitive Theory (SCT) will serve as the theoretic framework for behavior change techniques (BCT) threaded through the sleep health enhancement intervention. Participants will maintain a sleep diary during the program to aid in tailoring the program, self-monitoring of behavior, and feedback of behavior. Goals will be set by the participant at each session and reviewed at subsequent sessions, and motivational interviewing principles will be incorporated.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Health Enhancement Intervention | Experimental | The sleep health enhancement intervention is a 4-week, 1x/week one-one-one program with a graduate research assistant who will be trained and supervised by the PI in provision of the sleep health enhancement intervention. Receives: Behavioral: Sleep Health Enhancement Intervention |
| Wait-List Control Group | No intervention | The wait-list control group will be encouraged to continue with their usual activities and sleep habits during the wait period between baseline and reassessment and will undergo the sleep health enhancement intervention following the initial reassessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-item Acceptability Scale
5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
Measured: 6 week
semi-standardized qualitative interview
Feasibility and acceptability will be assessed via semi-structured interview with a trained graduate research assistant following standard qualitative methods to determine attitudes, perceptions and experiences of effectiveness, potential barriers, benefits, and likes/dislikes of the sleep health enhancement intervention. The interview will be recorded for analysis purposes
Measured: 6 week
Tilburg Frailty Indicator
The Tilburg Frailty Indicator consists of 15 questions with score ranging from 0-15 with a higher score indicating higher level of frailty. The physical, psychological, and social frailty sub scores range from 0-8, 0-4, and 0-3 respectively.
Measured: baseline, 6 week and 12 week reassessments
WHOQOL-BREF
The WHOQOL-BREF consists of 26 items and 4 domains of quality of life (psychological, physical health, social relationships and environmental). Scores range from 4-20 for each domain and a higher score indicates higher quality of life.
Measured: baseline, 6 week and 12 week reassessments
Ru_SATED sleep health composite
Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires. The domains will be summed to create the composite sleep health score ranging from 0-6 with a higher score indicating better sleep health.
Measured: baseline, 6 week and 12 week reassessments
Secondary outcomes (5)
Pittsburgh Sleep Quality Index
Scores range from 0-21 with a higher score indicating a lower quality of sleep. A global score of >5 indicates poor sleep quality.
Measured: baseline, 6 week and 12 week reassessments
Epworth Sleepiness Scale
Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness.
Measured: baseline, 6 week and 12 week reassessments
Dysfunctional Beliefs About Sleep
This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
Measured: baseline, 6 week and 12 week reassessments
Sleep Self-Efficacy
Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.
Measured: baseline, 6 week and 12 week reassessments
Actigraphy
Participants will wear an actigraph on their non-dominant wrist for 7 nights
Measured: baseline, 6 week and 12 week reassessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start12 Sep 2023
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Siengsukon, PT, PhD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968820
- Sponsor's protocol ID
- STUDY00150428
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring a Sleep Health Enhancement Intervention for Older Adults to Address Frailty
- ClinicalTrials.gov ID
- NCT05968820
- Acronym / sponsor ID
- STUDY00150428
- Conditions
- Frailty
- Keywords
- Sleep Health, Older Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 1 Aug 2023 (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.
The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. In the treatment development stage, we will recruit n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report questionnaire) to assess acceptability and tailor the sleep health enhancement intervention for older adults. In the pilot study stage to assess preliminary efficacy of the tailored sleep health enhancement intervention, n=30 older adults with poor sleep health will be randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement intervention or to a wait-list control condition. Participants will wear wrist-worn actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and reassessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Health Enhancement Intervention | Experimental | Behavioral: Sleep Health Enhancement InterventionThe sleep health enhancement intervention is a 4-week, 1x/week one-one-one program with a graduate research assistant who will be trained and supervised by the PI in provision of the sleep health enhancement intervention. |
| Wait-List Control Group | No intervention | –The wait-list control group will be encouraged to continue with their usual activities and sleep habits during the wait period between baseline and reassessment and will undergo the sleep health enhancement intervention following the initial reassessment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥65 years old
- ≤ 7 on the RU-SATED self-report questionnaire
- MMSE ≥25 and AD8 <3
Key exclusion criteria (13 listed)
- Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- >3 on the STOP BANG indicating increased risk of sleep apnea
- Evidence of restless legs syndrome on RLS-Diagnosis Index
- Evidence of circadian rhythm sleep-wake disorder
- Evidence of parasomnia
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 |
|---|---|---|
| Sleep Health Enhancement InterventionThe program is based on principles from CBT-I (time in bed restriction, stimulus control, relaxation techniques, sleep education) and includes behavioral strategies to entrain circadian rhythm, strengthen sleep homeostasis, reduce hyperarousal, and sleep hygiene techniques. Self-Determination Theory (SDT) and Social Cognitive Theory (SCT) will serve as the theoretic framework for behavior change techniques (BCT) threaded through the sleep health enhancement intervention. Participants will maintain a sleep diary during the program to aid in tailoring the program, self-monitoring of behavior, and feedback of behavior. Goals will be set by the participant at each session and reviewed at subsequent sessions, and motivational interviewing principles will be incorporated. | Behavioural | Sleep Health Enhancement Intervention |
Primary outcome
6-item Acceptability Scale
Time frame: 6 week
5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
semi-standardized qualitative interview
Time frame: 6 week
Feasibility and acceptability will be assessed via semi-structured interview with a trained graduate research assistant following standard qualitative methods to determine attitudes, perceptions and experiences of effectiveness, potential barriers, benefits, and likes/dislikes of the sleep health enhancement intervention. The interview will be recorded for analysis purposes
Tilburg Frailty Indicator
Time frame: baseline, 6 week and 12 week reassessments
The Tilburg Frailty Indicator consists of 15 questions with score ranging from 0-15 with a higher score indicating higher level of frailty. The physical, psychological, and social frailty sub scores range from 0-8, 0-4, and 0-3 respectively.
WHOQOL-BREF
Time frame: baseline, 6 week and 12 week reassessments
The WHOQOL-BREF consists of 26 items and 4 domains of quality of life (psychological, physical health, social relationships and environmental). Scores range from 4-20 for each domain and a higher score indicates higher quality of life.
Ru_SATED sleep health composite
Time frame: baseline, 6 week and 12 week reassessments
Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires. The domains will be summed to create the composite sleep health score ranging from 0-6 with a higher score indicating better sleep health.
5 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: baseline, 6 week and 12 week reassessments
Epworth Sleepiness Scale
Time frame: baseline, 6 week and 12 week reassessments
Dysfunctional Beliefs About Sleep
Time frame: baseline, 6 week and 12 week reassessments
Sleep Self-Efficacy
Time frame: baseline, 6 week and 12 week reassessments
Actigraphy
Time frame: baseline, 6 week and 12 week reassessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
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 Phase 1 study testing Sleep Health Enhancement Intervention in people with Frailty, run by University of Kansas Medical Center 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 3 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
6-item Acceptability Scale (time frame: 6 week). The study lists 5 primary outcomes in all. 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 19 Sep 2024.