| NCT ID | NCT07903896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hartford Hospital |
| Condition | Depressed Mood |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2026-10 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2026-10 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn how hot indoor temperatures affect mood in young adults with depression, with or without anxiety. It will also explore whether the time of day the heat happens matters, and whether changes in sleep, thinking, and daily activity help explain the effect. The main questions it aims to answer are: * Does heat during the day affect mood differently than heat at night? * Do changes in sleep, thinking, or activity help explain those effects? Researchers will compare a weekend that is hot during the day to a weekend that is hot at night to see how the timing of heat affects mood. Participants will take part for about four weeks. During that time, participants will: * Stay in a sleep lab for two weekends, two weeks apart. Each stay runs from Friday afternoon to Monday midday. * Spend one weekend in rooms that are hot (32°C, or 90°F) from 8 in the morning to 8 at night, and comfortable (22°C, or 72°F) overnight * Spend the other weekend in rooms that are comfortable (22°C, or 72°F) during the day and hot (32°C, or 90°F) overnight * Be woken up at 2 in the morning on the last night of each lab stay. Participants will answer questions and do short thinking tasks, then go back to sleep. * Wear sensors that track their sleep, heart rate, and body temperature, and swallow a small capsule that measures body temperature from the inside * Answer questions about their mood and do short thinking tasks, both in the lab and at home * Use a phone app for the whole four weeks of the study. The app asks about mood and sleep, and works with the sensors to track sleep, movement, heart rate, temperature, and humidity.
Eligibility Criteria
Inclusion Criteria: * 18 ≥ age ≤ 25 at time of consent * has current depression as measured by a PHQ-9 score \>9 and corroborated by the DIAMOND Diagnostic Interview * resides within 75 mi. of Yale Biobehavioral Laboratory * willing/able to travel up to 75 mi. each way by car from their home to the Yale Biobehavioral Laboratory and back to their home * speaks/reads English fluently (surveys, interviews, and study measures are only validated in English; translating materials without proper validation could lead to responses that are not truly comparable, threatening reliability; limitations in budget, staffing, and available interpreters prevent the use of translated materials or hiring sufficient bilingual team members) * any gender * any race/ethnicity * able (have capacity)/willing to sign informed consent form (ICF) * has reliable access to a smartphone Exclusion Criteria: * age \<18 or age ≥26 at time of consent * does not have current depression as indicated by a PHQ-9 score \<9 * does not reside within 75 mi. of Yale Biobehavioral Laboratory * not willing/able to travel up to 75 mi. each way by car from their home to the Yale Biobehavioral Laboratory and back to their home * does not speak/read English fluently * unable (not have capacity)/unwilling to sign informed consent form (ICF) * has a job that requires rotating shifts and/or works 2nd or 3rd shift (i.e., night shifts) that affect circadian rhythm and sleep architecture * planned air travel between time zones during the study period that is likely to affect circadian rhythm * does not have reliable access to a smartphone * is pregnant or lactating * has a recent history (hospital admission within 2 years) of heat-related illness (e.g. heat stroke, heat exhaustion, or rhabdomyolysis) * weight \< 40 kg (88 lbs) - minimum body weight requirement * has a motility disorder of the gastrointestinal tract * has undergone surgical procedures in the gastrointestinal tract * has known swallowing disorders or dysphagia * has any condition that affects normal digestive function (GERD requiring treatment; Barrett's esophagus; achalasia or esophageal stricture; gastroparesis; IBS; inflammatory bowel disease (Crohn's disease or ulcerative colitis); celiac disease; microscopic colitis; chronic constipation or chronic diarrhea; malabsorption syndromes (e.g., pancreatic insufficiency, bile acid malabsorption); chronic liver disease; chronic pancreatitis; symptomatic gallbladder or post-cholecystectomy syndrome; prior bariatric surgery or bowel resection with ongoing effects; ostomy; chronic motility disorders; diabetes with autonomic neuropathy; neurologic or systemic diseases affecting GI function (e.g., Parkinson's disease, multiple sclerosis, scleroderma); chronic medication-induced GI dysfunction; eating disorders affecting digestion or nutrition. * has any condition that affects the body's ability to regulate temperature, including, Neurological conditions (such as spinal cord injuries, multiple sclerosis, traumatic brain injury, Guillain-Barré syndrome); Endocrine/metabolic disorders (such as hyperthyroidism/hypothyroidism, Type 1 or 2 diabetes, and anorexia nervosa); Cardiovascular conditions (such as Reynaud's disease, hypertrophic cardiomyopathy, and congenital heart); Dermatological conditions, (such as anhidrosis or hyperhidrosis and extensive burns or scarring associated with trauma). * engage in regular alcohol use (\>2 drinks per day), daily cannabis use, or any illicit drug use which can affect sleep architecture
Contact & Investigator
Joshua R Wortzel, MD, MPhil, MS(Ed)
PRINCIPAL INVESTIGATOR
Hartford HealthCare
Frequently Asked Questions
Who can join the NCT07903896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 25 Years, studying Depressed Mood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07903896 currently recruiting?
Yes, NCT07903896 is actively recruiting participants. Contact the research team at Isaac.McAlister@hhchealth.org for enrollment information.
Where is the NCT07903896 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT07903896 clinical trial?
NCT07903896 is sponsored by Hartford Hospital. The principal investigator is Joshua R Wortzel, MD, MPhil, MS(Ed) at Hartford HealthCare. The trial plans to enroll 75 participants.