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New treatment option for Insomnia
Official title Noradrenergic Dysregulation, Sleep and Cognition in Older Adults With Insomnia
ClinicalTrials.gov ID: NCT06694441
What this study is testing
- What it's testing
- This study investigates the relationship between the noradrenergic (NA) system, sleep quality, and cognitive function in older adults with insomnia - a population at elevated risk for Alzheimer's disease-related dementias (ADRD) - compared to age and sex matched controls with normal sleep. The study characterizes NA function through multiple approaches: measuring 24-hour plasma levels of norepinephrine (NE) and its brain metabolite 3-methoxy-4-hydroxyphenylglycol (MHPG); evaluating central NA system response using the clonidine suppression test (a presynaptic α2 adrenoreceptor agonist that reduces locus coeruleus NA activity; and employing pupillometry as a non-invasive marker of autonomic function.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 55 years;
- Independent in activities of daily living and without clinically significant cognitive impairment as determined by a mini-mental status examination...
- Due to the effect of reproductive hormones on autonomic regulation, sleep and cognition, women will be postmenopausal;
- time spent in bed not greater than 8.5 hours;
- Sedentary, defined as participation in exercise of moderate intensity for less than 30 minutes per day and less than two times per week on a regular...
You likely can't join if
- Sleep disorders other than insomnia (restless legs syndrome, parasomnias, REM behavior disorder, circadian rhythm sleep-wake disorder, sleep apnea by...
- habitual bedtime before 9pm or morning awakening before 5am;
- History of neurological disorders;
- History of psychiatric disorders;
- A Beck depression inventory ((BDI-II) score greater than 19);
- Unstable or serious medical conditions;
See the full eligibility criteria
- Age ≥ 55 years;
- Independent in activities of daily living and without clinically significant cognitive impairment as determined by a mini-mental status examination (MMSE) score ≥ 26;
- Due to the effect of reproductive hormones on autonomic regulation, sleep and cognition, women will be postmenopausal;
- time spent in bed not greater than 8.5 hours;
- Sedentary, defined as participation in exercise of moderate intensity for less than 30 minutes per day and less than two times per week on a regular basis.
- average daily light exposure indicative of indoor environments (from questionnaire). for the insomnia group:
- Meet criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.);
- Subjective sleep efficiency less than 85% and/or awakening earlier than desired if before 6 AM for ≥3 nights/week in the previous 4 weeks;
- Subjective WASO (sWASO) ≥ 60 minutes for ≥3 nights/week in previous 4 weeks. sWASO will include time spent awake after sleep onset before final awakening + time spent awake in bed attempting to sleep after the final...
- global PSQI score greater than 5;
- average daily light exposure indicative of indoor environments (from questionnaire). for the control group:
- No history of chronic or short-term insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.);
- Subjective sleep efficiency greater than 85%;
- Subjective mean total sleep time of 6.5 hours to 8 hours;
- Habitual bedtime of 9PM-midnight;
- PSQI score ≤ 5. Participants in the control group will be matched with the insomnia group on sex and age (±3 years).
- Sleep disorders other than insomnia (restless legs syndrome, parasomnias, REM behavior disorder, circadian rhythm sleep-wake disorder, sleep apnea by STOP questionnaire and apnea hypopnea index (AHI) ≥ 15 by home sleep...
- habitual bedtime before 9pm or morning awakening before 5am;
- History of neurological disorders;
- History of psychiatric disorders;
- A Beck depression inventory ((BDI-II) score greater than 19);
- Unstable or serious medical conditions;
- Prediabetes and diabetes (HbA1C ≥ 5.7)
- Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);
- Use of medications that interfere with NA system activity including B-blockers, selective serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective norepinephrine-dopamine reuptake inhibitors (NDRIs);
- Hormone replacement therapy;
- Use of medications that affects pupil diameter and responses to light (i.e. antihistamines, anticholinergics, benzodiazepines, narcotics for pain;
- History of visual abnormalities that may interfere with pupillary responses to light exposure such as significant cataracts, narrow-angle glaucoma or blindness;
- History of heart conditions (i.e. arrhythmia, coronary artery disease, angina, heart failure);
- Shift work or other types of self-imposed irregular sleep schedules;
- BMI \> 35 kg/m2;
- History of habitual smoking (6 or more cigarettes/week) or caffeine consumption \> 400 mg/day. 17.Use of weight-loss medications
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.