Sleep QualityNCT07288775
Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders
A study testing Sleep enhancement intervention and Standard in people with Sleep Quality, run by Hospital Clinica Nova at 1 site in Mexico.
Trial summary
The goal of this randomized controlled clinical trial is to evaluate if the implementation of an adjusted nighttime medical order protocol can improve sleep quality and stabilize physiologic parameters in hospitalized adult patients admitted to general wards. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Sleep enhancement intervention and Standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteMexico
- Study dates
- 12 Apr 2024to 1 Jun 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients admitted within the past 24 hours
- Aged 18-65 years
- Hospitalized in the general ward of Hospital Clínica Nova
- Minimum in-hospital stay ≥ 3 days
- Visual Analog Scale for pain < 3
- Glasgow Coma Scale > 13
Who cannot join
- Visual, hearing, intellectual, or cognitive disability
- History of sleep disorders or obstructive sleep apnea
- Use of antidepressants, anxiolytics, hypnotics, or CNS stimulants
- Hemodynamic instability upon admission or during hospitalization
- Patients transferred from the ICU
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Clinica Nova de Monterrey
San Nicolás de los Garza, Nuevo León, 66450
About this study
Official title: Controlled Clinical Trial Between Sleep-Wake Quality and Adjustment of Nocturnal Medical Orders in Hospitalized Patients at Hospital Clinica Nova
The goal of this randomized controlled clinical trial is to evaluate if the implementation of an adjusted nighttime medical order protocol can improve sleep quality and stabilize physiologic parameters in hospitalized adult patients admitted to general wards.
The main questions it aims to answer are:
Read more
Does reducing non-urgent nocturnal medical interruptions increase total sleep time and REM duration? Does improving sleep continuity enhance subjective sleep quality and physiologic stability (heart rate, blood pressure)? Researchers will compare the intervention group (patients under an adjusted nighttime order protocol) with the control group (standard hospital care) to determine whether reorganizing nighttime medical routines improves objective and perceived sleep outcomes.
Participants will:
Wear a Fitbit Sense® device to continuously monitor objective sleep parameters across three hospital nights.
Complete the Pittsburgh Sleep Quality Index (PSQI) at admission and discharge to assess subjective sleep quality.
Undergo standard nighttime vital sign evaluations according to their assigned study protocol.
- Conditions
- Sleep Quality
- Being tested
- Sleep enhancement intervention, Standard
- Keywords
- sleep hygine, REM sleep, Non-REM sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep enhancement interventionBehavioural
Adjusted nocturnal medical orders
StandardBehavioural
Standard hospital care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Sleep enhancement intervention |
| Control | Placebo comparator | Not described Receives: Behavioral: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objetive changes in REM sleep
Change in REM sleep duration (minutes), objectively measured using the Fitbit Sense, after two consecutive nights with reduced nocturnal interruptions compared with one baseline night without modification of medical instructions, and between groups with and without the intervention.
Measured: 3 days
Subjective sleep quality changes
Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI), a validated instrument that evaluates subjective sleep quality across seven components. PSQI global scores will be compared between the intervention and control groups to determine whether reducing nocturnal interruptions is associated with improved subjective sleep-wake quality.
Measured: 3 nights
Secondary outcomes (5)
Differences in sleep-wake quality between male and female participants
Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that evaluates subjective sleep quality across seven components (sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, daytime dysfunction, and overall sleep quality). PSQI global scores will be compared between male and female participants to determine gender-related differences in sleep-wake quality
Measured: 3 nights
Association between sleep-wake quality and participant age
Sleep-wake quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). The association between PSQI global scores and participant age will be analyzed to determine whether increasing age correlates with changes in subjective sleep-wake quality.
Measured: 3 nights
Association between sleep-wake quality and body mass index (BMI).
Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The association between PSQI global scores and body mass index (BMI) will be explored to evaluate whether differences in BMI are related to variations in subjective sleep-wake quality.
Measured: 3 nights
Changes in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) between the intervention and control groups
Vital signs-including heart rate, respiratory rate, body temperature, and oxygen saturation-will be monitored using standard clinical measurement devices and/or Fitbit Sense sensor data (as applicable). Changes in these parameters will be compared between the intervention group and the control group to determine whether reducing nocturnal interruptions results in measurable physiologic differences.
Measured: 3 nights
Objective changes in NREM sleep
Change in NREM sleep duration (minutes), objectively measured using the Fitbit Sense, after two consecutive nights with reduced nocturnal interruptions compared with one baseline night without modification of medical instructions. And compared between groups with and without the intervention
Measured: 3 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start12 Apr 2024
- Primary completion1 Sep 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinica Nova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Elena Romero Ibarguengoitia, Hospital Clinica Nova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288775
- Sponsor's protocol ID
- Sleep
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trial Between Sleep-Wake Quality and Adjustment of Nocturnal Medical Orders in Hospitalized Patients at Hospital Clinica Nova
- ClinicalTrials.gov ID
- NCT07288775
- Acronym / sponsor ID
- Sleep
- Conditions
- Sleep Quality
- Keywords
- sleep hygine, REM sleep, Non-REM sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital Clinica NovaUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 17 Dec 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 goal of this randomized controlled clinical trial is to evaluate if the implementation of an adjusted nighttime medical order protocol can improve sleep quality and stabilize physiologic parameters in hospitalized adult patients admitted to general wards.
The main questions it aims to answer are:
Does reducing non-urgent nocturnal medical interruptions increase total sleep time and REM duration? Does improving sleep continuity enhance subjective sleep quality and physiologic stability (heart rate, blood pressure)? Researchers will compare the intervention group (patients under an adjusted nighttime order protocol) with the control group (standard hospital care) to determine whether reorganizing nighttime medical routines improves objective and perceived sleep outcomes.
Participants will:
Wear a Fitbit Sense® device to continuously monitor objective sleep parameters across three hospital nights.
Complete the Pittsburgh Sleep Quality Index (PSQI) at admission and discharge to assess subjective sleep quality.
Undergo standard nighttime vital sign evaluations according to their assigned study protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Sleep enhancement intervention |
| Control | Placebo comparator | Behavioral: Standard |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients admitted within the past 24 hours
- Aged 18-65 years
- Hospitalized in the general ward of Hospital Clínica Nova
- Minimum in-hospital stay ≥ 3 days
- Visual Analog Scale for pain < 3
Key exclusion criteria (5 listed)
- Visual, hearing, intellectual, or cognitive disability
- History of sleep disorders or obstructive sleep apnea
- Use of antidepressants, anxiolytics, hypnotics, or CNS stimulants
- Hemodynamic instability upon admission or during hospitalization
- Patients transferred from the ICU
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 enhancement interventionAdjusted nocturnal medical orders | Behavioural | Intervention |
| StandardStandard hospital care | Behavioural | Control |
Primary outcome
Objetive changes in REM sleep
Time frame: 3 days
Change in REM sleep duration (minutes), objectively measured using the Fitbit Sense, after two consecutive nights with reduced nocturnal interruptions compared with one baseline night without modification of medical instructions, and between groups with and without the intervention.
Subjective sleep quality changes
Time frame: 3 nights
Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI), a validated instrument that evaluates subjective sleep quality across seven components. PSQI global scores will be compared between the intervention and control groups to determine whether reducing nocturnal interruptions is associated with improved subjective sleep-wake quality.
5 secondary outcomes
Differences in sleep-wake quality between male and female participants
Time frame: 3 nights
Association between sleep-wake quality and participant age
Time frame: 3 nights
Association between sleep-wake quality and body mass index (BMI).
Time frame: 3 nights
Changes in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) between the intervention and control groups
Time frame: 3 nights
Objective changes in NREM sleep
Time frame: 3 nights
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 12 Jun 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. 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 study testing Sleep enhancement intervention and Standard in people with Sleep Quality, run by Hospital Clinica Nova at 1 site in Mexico.
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 6 inclusion and 5 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 12 Jun 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 Mexico. 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 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?
Objetive changes in REM sleep (time frame: 3 days). The study lists 2 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 12 Jun 2026.