Insomnia study: Light Exposure
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
- The study looks at how a brain chemical called norepinephrine (NE) relates to sleep and memory in older people who have trouble sleeping, and whether bright light can help.
- Who it's for
- Older adults who have insomnia and are willing to give blood samples and take part in tests.
- What's involved
- Participants will give blood samples, have a special eye test, and take a medication test to measure NE levels. They will also receive bright light therapy during the day and have sleep and memory tests.
- Time commitment
- The study lasts several weeks, with multiple visits for blood draws, eye and medication tests, and daily bright light exposure sessions.
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.
- 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;
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.