SleepPhase 1/2NCT07251452
Nurse-Led Elderly Sleep Intervention
A Phase 1/2 study testing Otago programme and Otago programme + Cognifit in people with Sleep and Gerontology, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The present clinical trial aims to test whether a dual program of physical activity and cognitive training improves sleep and quality of life in people over 65 years of age. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Gerontology, Physical Therapy
- What is being tested?
- Otago programme and Otago programme + Cognifit
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 28 Feb 2026
- Phase
- Phase 1/2
- 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
- know how to use smartphones.
- have the ability to perform physical activity.
Who cannot join
- be under 65 years of age.
- suffer from serious pathologies that prevent the intervention from being carried out.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Physiotherapy and Nursing, Arms Factory, Toledo, 45071 Spain
Toledo, Toledo, 45005
About this study
Official title: Efficacy of a Nurse-developed Physical and Cognitive Program to Improve Sleep and Quality of Life in Elderly: Randomized Clinical Trial
The present clinical trial aims to test whether a dual program of physical activity and cognitive training improves sleep and quality of life in people over 65 years of age.
Read the detailed description
The intervention is being carried out in different day centers and co-housing centers in Toledo, Spain, where participants were recruited. A three-arm study was also conducted: a control group that received talks on health topics; a physical activity intervention group that followed the Otago physical activity program, tailored to; and a physical activity and cognitive training intervention group that used a mobile app known as Cognifit to develop the cognitive intervention.
- Conditions
- Sleep, Gerontology, Physical Therapy, Cognitive
- Being tested
- Otago programme, Otago programme + Cognifit, Control
- Keywords
- quality of life, sleep, physical activity, cognitive intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago programmeBehavioural
Otago physical activity program adapted to elderly people
Otago programme + CognifitBehavioural
Otago physical activity program adapted for seniors and cognitive training with the Cognifit app for smartphones or tablets.
ControlBehavioural
Talks about topics of interest in health sciences not related to sleep
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Talks are given on health education topics that are not related to the intervention to the participants. Receives: Behavioral: Control |
| Otago programme | Experimental | a physical activity intervention is applied to the participants. Receives: Behavioral: Otago programme |
| Otago programme + Cognitift | Experimental | a physical activity and cognitive training intervention is applied to the participants. Receives: Behavioral: Otago programme + Cognifit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Latency, sleep efficiency, number of awakenings during the night will be measured by actigraphy.
The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to asees objetive sleep quality and patterns in adults. It consists of 19 self-reported items. The 9 self-reported items of the PSQI generate seven component scores (with subscales ranging from 0 to 3): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. The sum of these seven component scores produces an overall subjective sleep quality score (ranging from 0 to 21). Higher scores indicate poorer subjective sleep quality.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Secondary outcomes (10)
Quality of life in older people
European Quality of Life 5 Dimensions (EQ-5D) will be used. Maximum score: 100, representing "best possible health." Minimum score: 0, representing "worst possible health."
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Cognitive assessment and training
The CogniFit® computerized battery for smart devices is used for neurocognitive assessment and training of various cognitive functions, such as memory, attention, planning, processing speed, and cognitive flexibility. The CogniFit® neurocognitive assessment uses a series of interactive tasks and exercises to measure the status of different cognitive domains, providing detailed quantitative and graphical results that allow for the identification of strengths and areas for improvement. It has been previously validated in older adults, demonstrating good internal consistency (Cronbach's alpha = 0.85-0.88) and test-retest reliability (r = 0.69-0.92). The neurological assessment provides an overall score expressed in normative scores compared to similar populations, facilitating its interpretation in both clinical and research contexts. In addition, it offers cognitive training exercises.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Sociodemographic variables
Questionnaire on sociodemographic variables of own elaboration will be used for the collection of sociodemographic, anthropometric and health and drug-related data.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Degree of independence of older people in performing Basic Activities of Daily Living (BADLs)
The Katz Index, will be used to assess the level of independence of older adults in performing Basic Activities of Daily Living (BADLs). This instrument measures functional capacity in essential daily living tasks, providing an objective view of the level of dependence or autonomy of the person being evaluated. The index assesses six basic functions: bathing, dressing, toileting, mobility, continence, and feeding. (6) points: Independent in all activities. (0) points: Dependent in all activities.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Functional capacity in Instrumental Activities of Daily Living
The Lawton and Brody scale will be used to assess functional capacity in Instrumental Activities of Daily Living (IADLs), which are more complex tasks than basic activities and require more advanced cognitive and physical skills.
0 points: Total dependence. 8 points: Total independence (for women, and 5 for men).
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Level of social support and social network of older adults
The Lubben Social Network Scale (LSCS) will be used to assess the level of social support and social network of older adults. It consists of six items scored on a 0-to-5 Likert scale. Higher scores reflect larger social networks and greater availability of social support. Conversely, scores below indicate a high risk of social isolation.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Depression
Yesavage Geriatric Depression Scale will be used. Consists of 15 dichotomous (yes/no) questions, in which each item is scored 0 or 1 depending on the response.
0-5 points: Normal. 6-9 points: Mild depression. > 10 points: Established depression.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Mobility
The Timed Up and Go (TUG) test will be used to assess balance, mobility, and fall risk in older adults. The test involves recording the time it takes a person to perform the following tasks: stand up from a chair with armrests, walk a distance of 3 meters marked on the floor, turn around, return to the chair, and sit down again. The total time is measured in seconds using a stopwatch. According to the standards, a time of less than 10 seconds indicates excellent mobility, while times greater than 20 seconds suggest limited mobility and a higher risk of falls.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.
Memory
The Memory Failures of Everyday (MFE) questionnaire will be used to assess everyday memory lapses. It consists of 28 items and is answered using a three-point Likert scale (Montejo et al. version) ranging from 'never in the last three months' to 'more than once a day'. Lower scores indicate fewer lapses, while higher scores indicate more lapses.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.
Cognitive disorders
Lobo Mini-Mental State Examination (36-item version) will be used to assess cognitive impairment associated with neurodegenerative diseases. It consists of several items that evaluate five cognitive domains: memory, orientation, attention span, calculation, concentration, and language. In geriatric patients over 65 years of age, scores below 23 are considered indicative of cognitive impairment; in patients under 65 years of age, scores of 27 or below are considered indicative of cognitive impairment.
Measured: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Sep 2025
- Primary completion15 Sep 2025
- Study completion28 Feb 2026
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Pilar de Paz Montón, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251452
- Sponsor's protocol ID
- Gerontology-sleep
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nurse-developed Physical and Cognitive Program to Improve Sleep and Quality of Life in Elderly: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07251452
- Acronym / sponsor ID
- Gerontology-sleep
- Conditions
- Sleep, Gerontology, Physical Therapy, Cognitive
- Keywords
- quality of life, sleep, physical activity, cognitive intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 26 Nov 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.
The present clinical trial aims to test whether a dual program of physical activity and cognitive training improves sleep and quality of life in people over 65 years of age.
Detailed description
The intervention is being carried out in different day centers and co-housing centers in Toledo, Spain, where participants were recruited. A three-arm study was also conducted: a control group that received talks on health topics; a physical activity intervention group that followed the Otago physical activity program, tailored to; and a physical activity and cognitive training intervention group that used a mobile app known as Cognifit to develop the cognitive intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: ControlTalks are given on health education topics that are not related to the intervention to the participants. |
| Otago programme | Experimental | Behavioral: Otago programmea physical activity intervention is applied to the participants. |
| Otago programme + Cognitift | Experimental | Behavioral: Otago programme + Cognifita physical activity and cognitive training intervention is applied to the participants. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- know how to use smartphones.
- have the ability to perform physical activity.
Key exclusion criteria (2 listed)
- be under 65 years of age.
- suffer from serious pathologies that prevent the intervention from being carried out.
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 |
|---|---|---|
| Otago programmeOtago physical activity program adapted to elderly people | Behavioural | Otago programme |
| Otago programme + CognifitOtago physical activity program adapted for seniors and cognitive training with the Cognifit app for smartphones or tablets. | Behavioural | Otago programme + Cognitift |
| ControlTalks about topics of interest in health sciences not related to sleep | Behavioural | Control |
Primary outcome
Sleep
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Latency, sleep efficiency, number of awakenings during the night will be measured by actigraphy. The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to asees objetive sleep quality and patterns in adults. It consists of 19 self-reported items. The 9 self-reported items of the PSQI generate seven component scores (with subscales ranging from 0 to 3): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. The sum of these seven component scores produces an overall subjective sleep quality score (ranging from 0 to 21). Higher scores indicate poorer subjective sleep quality.
10 secondary outcomes
Quality of life in older people
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Cognitive assessment and training
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Sociodemographic variables
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Degree of independence of older people in performing Basic Activities of Daily Living (BADLs)
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Functional capacity in Instrumental Activities of Daily Living
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Level of social support and social network of older adults
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Depression
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Mobility
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.
Memory
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.
Cognitive disorders
Time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.
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 22 May 2026.
- 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.
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 1/2 study testing Otago programme and Otago programme + Cognifit in people with Sleep and Gerontology, run by University of Castilla-La Mancha at 1 site in Spain.
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 2 inclusion and 2 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 22 May 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 Spain. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sleep (time frame: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).). 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 22 May 2026.