Is NCT07848594 recruiting in Newton Center, MA?

Yes, NCT07848594 is currently recruiting participants at its Newton Center, MA location. This poor sleep quality clinical trial is actively enrolling qualified participants.

How do I join the poor sleep quality clinical trial in Newton Center?

To join this clinical trial in Newton Center, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Newton Center clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Poor Sleep Quality Clinical Trial in Newton Center, MA

About This Poor Sleep Quality Study in Newton Center

This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with self-reported poor sleep.

Sponsor: Eight Sleep Inc.

Who Can Participate

Inclusion Criteria

All Cohorts

45 years of age or older

Self-reported poor sleep quality: PSQI score greater than 5

Within 1.5 hours driving of the Greater Boston area

Have never used an Eight Sleep Pod (or similar device) ever

Post-enrollment hsCRP ≤ 10 µg/mL at Preparation Period blood panel. If Preparation Period hsCRP \> 10 µg/mL: triggers clinical review on a case by case basis; hard

Exclusion Criteria

applies only at \> 30 µg/mL Weight ≥ 88 lbs

No MRI scheduled during the study period or within 1 week after study conclusion

No acute illness, injury, or dental procedure/cleaning within 3 months prior to study start

Non-smoker or previous infrequent (\<1 weekly) smoker who has ceased at least 3 months prior to study start

Predictable bowel movements: at least 3 weekly and no more than 3 daily bowel movements

Able to drive or be transported to a local lab facility at least three total times for blood panels

Willing to complete 3 blood panels (3-4 tubes of blood collected at each draw): no strong aversion to needles

Able to swallow a pill/capsule (approximately the size of the standard vitamin capsule) for internal core temperature monitoring

Stable diet for a minimum of 3 months prior to enrollment, with no planned major dietary changes during the study period

Stable medication regimen: no medication type or dose changes within 3 months prior to study start, and no plans to change medications during the study. This includes long-term -medication like antidepressants, statins, hormones, antihypertensives, or levothyroxine.

Stable exercise routine for a minimum of 3 months prior to study start, with no planned changes to this routine

Stable dietary supplement routine for a minimum of 3 months prior to the study start: includes probiotics, synbiotics, supplemental SCFA's

Willing to receive, set-up, and use all required equipment: the Eight Sleep Pod Cover and Hub, biometric smart ring, urine-based hormone measurement kit, ambulatory blood pressure monitor, core temperature capsule, HST device, and stool collection kits for the required amount of time

Comfortable using research accounts owned by Eight Sleep for some study devices

Willing and able to have stool samples picked up by the research team three and up to five times during the study

Willing to have the research team in the home for study set-up (up to 3 hours)

Have a valid, government issued ID Cohort A specific Inclusion: Postmenopausal women

Assigned female at birth

Postmenopausal: self-reported absence of menstrual period for 12 or more consecutive months prior to study start

No change to hormone replacement therapy (HRT) use within 3 months prior to study start or plans to change HRT status during study period

No changes to hormonal birth control use within 3 months prior to study start or plans to change birth control use during study period Cohort B specific Inclusion: Age-Matched Men -Assigned Male at birth Exclusion Criteria: All Cohorts

Currently taking any of the following medications/supplements or have changed use status (using to not using or vice versa) within 3 months before study start.

Antibiotics (any kind), including one-time or short-term antibiotic use

Corticosteroids (oral or injection only, topical preparations included):

Prednisolone

Dexamethasone

Hydrocortisone

Methylprednisolone (Medrol)

Betamethasone

Anti-TNF-α medications (biologics for arthritis, Crohn's disease, psoriasis, or other immune/inflammatory conditions):

Adalimumab (Humira)

Etanercept (Enbrel)

Infliximab (Remicade)

Certolizumab (Cimzia)

Golimumab (Simponi)

Changed use status (using to not using or vice versa) within 3 months before study start or plans to stop/start the medications during the study. --Statins (cholesterol-lowering medications):

Atorvastatin (Lipitor)

Rosuvastatin (Crestor)

Lovastatin (Mevacor)

Fluvastatin (Lescol)

Antihypertensive drugs (blood pressure medications):

Angiotensoconverting enzyme (ACE) inhibitors: Lisinopril, Ramipril, Perindopril, Enalapril

Angiotensin II receptor blockers (ARBs): Losartan, Valsartan, Candesartan

Calcium channel blockers: Amlodipine (Norvasc), Diltiazem, Verapamil

Beta-blockers: Metoprolol, Atenolol, Bisoprolol, Propranolol

Diuretics: Hydrochlorothiazide, Furosemide (Lasix), Indapamide

Changed use status (using to not using or vice versa) within 3 months before study start or plans to start/stop during the study.

Hormonal birth control (any form): ---Combined oral contraceptives (estrogen + progestin) or progestin-only capsule

Hormonal IUD (e.g. Mirena, Kyleena)

Contraceptive implant (e.g. Nexplanon)

Contraceptive injection (e.g. Depo-Provera)

Contraceptive patch (e.g. Xulane, Evra)

Vaginal ring (e.g. NuvaRing)

Hormone replacement therapy (exceptions: systemic - local vaginal estrogen preparations are not excluded):

Estrogen-based: oral tablets, patches, gel, cream, or vaginal ring

Combined estrogen + progestogen: oral tablets or patches

Progesterone-based: oral tablets or intrauterine device

Testosterone: cream or gel

Bioidentical: oral tablets, patches, gel, cream, pellets, or injections

Testosterone-based: testosterone enanthate, cypionate, propionate, Sustanon

Synthetic anabolic steroids: nandrolone, stanozolol (Winstrol), oxandrolone (Anavar), methandrostenolone (Dianabol), trenbolone

GLP-1 receptor agonists or other glucose-lowering medications:

GLP-1s: Semaglutide (Ozempic, Wegovy), Liraglutide (Victoza, Saxenda), Dulaglutide (Trulicity), Tirzepatide (Mounjaro, Zepbound)

Other: Metformin (Glucophage), Insulin (all types), Sitagliptin (Januvia), Empagliflozin (Jardiance), Dapagliflozin (Farxiga), Glipizide, Glyburide

Currently taking any of the following medications/supplements or have changed use status (using to not using or vice versa) within 3 months before study start or plans to start/stop taking these drugs during the study period. --Sleep medications: Prescription: Zolpidem (Ambien), Zopiclone (Imovane), Eszopiclone (Lunesta), Temazepam, Nitrazepam, Trazodone (when prescribed for sleep), Suvorexant (Belsomra) Over-the-counter: Diphenhydramine (Benadryl, ZzzQuil, Unisom), Doxylamine (Unisom SleepTabs, Nytol), --Benzodiazepines (use status change within 12 months before study start): Diazepam (Valium), Lorazepam (Ativan), Clonazepam (Klonopin), Temazepam, Nitrazepam

Antidepressant medications (change within 3 months of study start or plans to start/stop taking during the study period)

Stimulants affecting blood pressure:

Methylphenidate (Ritalin, Concerta)

Amphetamine/Dextroamphetamine (Adderall)

Lisdexamfetamine (Vyvanse)

Modafinil (Provigil)

Pseudoephedrine (Sudafed, including other cold/decongestant medications)

Antipsychotics: Quetiapine (Seroquel), Olanzapine (Zyprexa), Risperidone

Mood stabilizers: Lithium, Valproate (Depakote)

Changed use status (using to not using or vice versa) within 3 months before study start or during the study. --CBT-I or pharmacological treatment for insomnia disorder

Changed use status (started or stopped using) within 3 months before study start.

Probiotics, prebiotics, or synbiotics

Butyrate (Sodium butyrate, Calcium/magnesium butyrate, Tributyrin), Acetate, Propionate

Multivitamins containing any of the following minerals:

Iron, Selenium, Calcium, Zinc, Phosphorus, Magnesium Note: Stable long-term multivitamin use (unchanged for ≥3 months) is not excluded Folic Acid, Vitamin C, Vitamin A, Vitamin D, or Vitamin E supplements

Antioxidant supplements

Omega-3 / fish oil supplements

Melatonin (current use excluded if unwilling to cease use during study participation)

Current, ongoing, or history of diagnosis or changed diagnosis status (new diagnosis, revised or reversed diagnosis) within the specified timeframe.

Metabolic Conditions

Diabetes mellitus: Type 1

Type 2 diabetes (within the past 3 years)

Diagnosed prediabetes (confirmed via Preparation Period hbA1c levels. A result between 5.7-6.4% warrants exclusion from the study)

Chronic hepatitis B/C

Liver cirrhosis

Alcoholic liver disease

Non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) (within the past 3 years)

Hepatitis A (within the past 3 years)

Hypothyroidism or hyperthyroidism (including Hashimoto's thyroiditis)

Cardiovascular Conditions

Hypertension

Cardiovascular disease, including:

Coronary artery disease (CAD) or ischemic heart disease

History of myocardial infarction (heart attack)

Heart failure (any grade)

Atherosclerosis

History of stroke or transient ischemic attack (TIA)

Peripheral arterial disease (PAD)

Atrial fibrillation or other major cardiac arrhythmias

Vasovagal syncope: common fainting episode caused by a sudden drop in blood pressure and heart rate

Severe anemia or significant white blood cell or platelet abnormalities

Surgery, severe skin disease, or fistula on the upper arm (interfering with BP cuff readings; within 3 months prior to the study start)

Autoimmune Conditions

Rheumatoid arthritis

Ankylosing spondylitis

Lupus erythematosus

Multiple sclerosis (MS)

Any other diagnosed autoimmune condition or current use of immunosuppressive medications

Gastrointestinal Conditions

Inflammatory bowel disease (IBD), Crohn's disease or ulcerative colitis

Irritable bowel syndrome (IBS)

Celiac disease

Gastroparesis or diverticular disease

History of colostomy, colon cancer, or other colon-related surgeries

Recent gastrointestinal surgery (within 6 months prior to enrollment)

Chronic Diseases

Renal disease (chronic kidney disease, any stage)

Hepatic disease (beyond those listed under metabolic conditions above)

Respiratory or chronic lung disease

Neurological and Psychological Conditions

Alzheimer's disease

Parkinson's disease

Schizophrenia

Sleep-Related Conditions

Obstructive sleep apnea (OSA)

Central sleep apnea

Complex sleep apnea syndrome

Narcolepsy or hypersomnia disorders

Restless legs syndrome (RLS) / Willis-Ekbom disease

Periodic limb movement disorder (PLMD)

Circadian rhythm sleep-wake disorders: shift work disorder (SWD), irregular sleep-wake rhythm disorder (ISWRD), or non-24-hour sleep-wake disorder (N24SWD) Note: Participants with delayed sleep-wake phase disorder (DSWPD) or advanced sleep-wake phase disorder (ASWPD) with chronically stable sleep timing may be included.

Participants will be excluded if they participate in any of the following behaviors or conditions within the indicated timeframe.

Substance Use

Current addiction to opiates

Excessive alcohol consumption (more than 14 standard drinks per average 1 week)

Habitual caffeine consumption exceeding 400 mg per day (approximately 4 standard cups of coffee or equivalent)

Recreational frequent drug use within timeframes noted prior to study start:

Cannabis / marijuana (including edibles and oils): daily or near-daily use (defined as ≥5 days per week) within 3 months prior to study start

Cocaine: any use within 3 months prior to study start

MDMA / ecstasy: any use within 3 months prior to study start

Hallucinogens (LSD, psilocybin): any use within 4 weeks prior to study start

Ketamine or other illicit substances: any use within 3 months prior to study start

Diet and Weight

Planning significant changes to diet or lifestyle in the 3 months prior to study start, or had significant changes to diet or lifestyle in the 3 months prior to study start

Starting or stopping a specialized diet (ketogenic, vegan, carnivore, elimination, intermittent fasting)

Significant increase or decrease in exercise load or training plan (change of ≥60 minutes per week in total exercise volume, starting or stopping a structured exercise program, or injury/illness-related activity restriction) within 3 months prior to study start

Currently enrolled in an active weight-loss program, bariatric program, or medically supervised diet, or planning to start one during the study

Weight loss or gain within the past 1 month of 5% of body weight or greater,, or weight loss or gain within the past 6 months of 10% body weight or greater

Health Status at Enrollment ---Acute illness or active infection at the time of recruitment or study start: includes colds, prolonged cough, fevers, etc.

Active cancer diagnosis or receipt of chemotherapy or radiotherapy within 12 months prior to study start, or planned chemotherapy treatment during the study duration

Hospitalization of greater than 24 hours for acute illness, major surgery, sepsis, or cardiac, pulmonary or neurological events within 6 months prior to study start

Study Equipment Compatibility

Unable or unwilling to swallow a standard-sized capsule (required for internal core temperature monitoring capsule)

Currently using a pacemaker or other electromagnetic medical implant (contraindicated with core temperature capsule)

MRI scheduled during the study period or within 1 week after study conclusion

Have or may have a CT scan planned during the study period

Allergic to nickel or aluminum

Sample and Data Collection ---Unable or unwilling to ----Collect and provide at least 3, and up to 5, stool samples ----Store self-collected stool samples in a home freezer until shipment/pick-up (up to 1 week after collection) ----Complete 3 blood panels (3-4 tubes of blood each), including strong aversion to needles ----Complete required digital surveys and any requested data sharing

Communicate with the research team within a timely manner throughout the duration of the study

Have stool samples picked up from home

Have research staff within home for study set-up for up to 3 hours

Complete all data collection requirements in a timely manner

Lifestyle and Compliance

Travel planned during the study period

Unstable WiFi connection at any point during the study period (to the best ability this can be predicted)

Unwilling or unable to provide informed consent with sufficient mental wellness to understand the study

Lived outside of the United States within 6 months prior to study start Cohort A Exclusion Criteria: Postmenopausal women

Hysterectomy

Oophorectomy (single or double)

Polyendocrine metabolic ovarian syndrome (PMOS), previously known as polycystic ovarian syndrome (PCOS)

Diagnosed testosterone dysregulation (hyperandrogenism or androgen insufficiency) not attributable to PMOS

Premature ovarian insufficiency (POI) or premature ovarian failure (POF)

Endometriosis

Change to hormone replacement therapy (HRT) use within 3 months prior to study start

Changes to hormonal birth control use within 3 months prior to study start Cohort B Exclusion Criteria: Age-Matched Men -Diagnosed testosterone dysregulation (hyperandrogenism and/or androgen insufficiency)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Newton Center?

Yes, this clinical trial (NCT07848594) has an active research site in Newton Center, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Poor Sleep Quality Treatment Options in Newton Center, MA

If you're searching for poor sleep quality treatment options in Newton Center, MA, this clinical trial (NCT07848594) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Newton Center research site is actively enrolling participants for this clinical trial. You'll receive care from experienced poor sleep quality specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all poor sleep quality clinical trials near you to find additional studies recruiting in your area.

Poor Sleep Quality Clinical Trial in Newton Center, MA

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