Targeted Sleep Intervention for Sleep

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC-Boulder Clinical and Translational Research Center, Boulder, CO
Sleep+1 More
Targeted Sleep Intervention - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in adults with elevated blood pressure.

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Eligible Conditions

  • Sleep
  • Blood Pressures

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Targeted Sleep Intervention will improve 16 primary outcomes and 6 secondary outcomes in patients with Sleep. Measurement will happen over the course of The Epworth Sleepiness scale questionnaire will be administered during Phase 1 at the participants week 1 visit..

Week 1
Phase 1: Diastolic Blood Pressure (DBP)
Week 8
Phase 2: Diastolic Blood Pressure (DBP)
Week 3
Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)
Week 13
Phase 2: FBF response to Acetylcholine (ACh)
Week 3
Phase 1: FBF response to ACh+L-NMMA
Week 13
Phase 2: FBF response to ACh+L-NMMA
Week 3
Phase 1: FBF response to L-NMMA
Week 13
Phase 2: FBF response to L-NMMA
Week 3
Phase 1: FBF response to Sodium Nitroprusside (NTP)
Week 13
Phase 2: FBF response to Sodium Nitroprusside (NTP)
Week 4
Phase 1: Sleep
Week 12
Phase 2: Sleep
Week 1
Phase 1: Systolic Blood Pressure (SBP)
Week 8
Phase 2: Systolic Blood Pressure (SBP)
Week 1
Phase 1: Epworth Sleepiness Scale
Week 8
Phase 2: Epworth Sleepiness Scale
Week 1
Phase 1: Pittsburgh Sleep Quality Index (PSQI)
Week 8
Phase 2: PSQI
Week 1
Phase 1: Insomnia Severity Index
Week 8
Phase 2: Insomnia Severity Index
Week 3
Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)
Week 13
Phase 2: Endothelial t-PA Release in response to Bradykinin (BDK)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Phase 1
1 of 2
Phase 2
1 of 2
Active Control
Experimental Treatment

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Targeted Sleep Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Phase 2
Other
Phase II is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in adults with elevated blood pressure who habitually sleep less than 6.5 hr/night (Specific Aims 3).
Phase 1Phase I is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in adults with elevated blood pressure who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 6.5 hr/night (short sleep)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: t-pa release will be measured during phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly t-pa release will be measured during phase 2 at the participants visit 9 which is ~13 weeks from their respective start date. for reporting.

Who is running the study

Principal Investigator
C. D.
Prof. Christopher DeSouza, Professor
University of Colorado, Boulder

Closest Location

UC-Boulder Clinical and Translational Research Center - Boulder, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Physical examination is a process that a doctor uses to check a patient's health show original
They have been determined to be sedentary from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and have not engaged in any program of regular physical activity for at least 6 months prior to the study. show original
Subjects will be prehypertensive/hypertensive if their resting systolic blood pressure is 125-159 mmHg or their resting diastolic blood pressure is 75-99 mmHg. show original
Subjects that have a pre-existing diagnosis of obstructive sleep apnea, or are determined to have obstructive sleep apnea based on their sleep disorders screening visit, will be allowed to participate in the study but will not take part in the sleep intervention/post sleep intervention visits. show original
medical history;
This study will include men and women of all different races and ethnic backgrounds between the ages of 45 and 65. show original
Most women will experience menopause at some point, even if they're not taking hormone replacement therapy. show original
The study assessed the electrocardiogram and BP at rest and maximal exercise in a group of healthy volunteers. show original

Patient Q&A Section

What causes sleep?

"In this sample, genetics play a major role in determining sleep and determining sleep in the morning, suggesting that circadian genetics may play a role in the morning sleep onset response." - Anonymous Online Contributor

Unverified Answer

How many people get sleep a year in the United States?

"Average yearly sleep among nonwhite adults was 9.9 hours per person. Sleep was significantly greater if they lived in the South and had no children. Sleep increased with age for both sexes. Most studies do not report the level of error in their estimates. The level of error is greatest for the elderly and for non-whites. Sleep was highest among those with no children, while most with children slept 5 hours/night in 2003–2004. Sleep was lower among those who worked rotating shifts or in factories. This might indicate more workers with more sleep deficit than those with less. Sleep in the elderly was similar to younger people, although it was slightly lower among non-whites. Sleep was lower in men than in women." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleep?

"There are many techniques to treat sleep problems. Some common treatments for sleep include bedtime routines, relaxation, cognitive therapy, relaxation therapy, psychoeducation and exercise. There is no proof that one method will help faster than another approach.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of sleep?

"Sleep disturbances are one of the most common symptoms of all conditions and are associated with many others. The disturbances include insomnia, sleep fragmentation, circadian rhythm sleep disorders, non-restorative sleep and hypersomnolence." - Anonymous Online Contributor

Unverified Answer

Can sleep be cured?

"Each individual may experience some benefit from the improved nighttime sleep they will obtain from regular use of a CPAP device. However, the improvement in sleep quality obtained from use of this CPAP device adds no benefit when compared to using the CPAP device during the daytime when patients return to work." - Anonymous Online Contributor

Unverified Answer

What is sleep?

"Sleep has been an integral part of our lives since before humans could even sleep and is important in the health of each individual. It has been suggested that sleep is involved in memory consolidation and learning mechanisms in the brain. Current sleep research has provided a better understanding of the role of sleep. It has been demonstrated that the brain uses different parts of the sleep cycle for different functions and its structure and function is not the same throughout the cycle. A recent study found that sleep can beneficially influence certain aspects of memory and learning by altering the levels of certain chemicals such as catecholamines and acetylcholine and their receptors in our brains." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving targeted sleep intervention?

"There is some evidence that TSI as an active treatment may be an appropriate intervention, but given the wide range of interventions evaluated it is hard to know which treatment is optimal. In addition, there is insufficient evidence to make a firm conclusion on the effectiveness of TSI as an adjunct for patients with insomnia due to depression. Further high quality randomized controlled trials and trials to compare active treatments are needed." - Anonymous Online Contributor

Unverified Answer

Is targeted sleep intervention typically used in combination with any other treatments?

"The majority of the intervention studies found showed that TSI was typically employed in combination with other treatments. Results from a recent clinical trial suggest that TSI is effective in treating insomnia, with or without other treatments. However, due to the small sample size of the studies included, further research should be conducted to verify the generalizability of the data to show more clarity about TSI intervention’s effectiveness in combination with other treatments." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets sleep?

"People with low socioeconomic status (SES) in Saudi Arabia have shorter sleeping duration and this finding is particularly evident in women. This finding needs to be further investigated by taking into account the socio-economical, gender and cultural context in this socio-cultural environment. Understanding the relationship between the duration of sleep and SES would be helpful in the future to design interventions that would increase the duration of sleep among these individuals. In addition, it would be important to examine whether there is a difference between the duration of sleep of Saudi Arabian youths and adolescents." - Anonymous Online Contributor

Unverified Answer

What is targeted sleep intervention?

"The most important target in treatment of insomnia is, as we believe, to get rid of the problem itself and consequently the negative consequences of both insomnia and circadian rhythm. In our series we found a negative treatment effect, which may be explained by the severity of insomnia itself, the side effects of treatment modality (drug or non-drug treatment) or the concurrent use of additional therapy modules (sleep therapy and cognitive behavioral therapy). Results from a recent clinical trial suggest that the best way to achieve and maintain symptom and sleep regulation is to provide patients with the most effective, least complicated therapy modality." - Anonymous Online Contributor

Unverified Answer

Does targeted sleep intervention improve quality of life for those with sleep?

"A total sleep time of >8 h/day improves health-related QOL and provides significant sustained benefits to CVD health outcomes, without serious adverse reactions. Further studies may elucidate the relationship between the impact of sleep duration on QOL and potential mechanisms of improvement in CVD." - Anonymous Online Contributor

Unverified Answer

Is targeted sleep intervention safe for people?

"Although the current study did not have the definitive number of participants needed to test for efficacy, the study was designed to determine safety of the protocol. Given that the study had sufficient power given the number of participants, the study will yield reliable results." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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