Recruiting

Observational Study

Sponsor:

University of Arizona

Code:

NCT07438912

Conditions

Suicidal Ideation

Circadian Rhythm Disorders

Sleep Deprivation

Sleep Wake Disorders

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Sleep Pressure Manipulation

Study Details

Brief summary:

This study examines whether wakefulness during the biological night (2:00-4:00 AM) is associated with increased negative mood, impaired decision-making, and suicidal thoughts. Adults with a history of suicidal ideation in the past six months will complete laboratory and home-based assessments under varying levels of sleep pressure. Participants will be evaluated during late-night wakefulness and under conditions of both higher and lower sleep pressure. The goal of the study is to better understand the biological and behavioral mechanisms that may contribute to elevated suicide risk during nocturnal wakefulness.

Conditions

Suicidal Ideation

Circadian Rhythm Disorders

Sleep Deprivation

Sleep Wake Disorders

Study ID

NCT07438912

Start date

Mar 6, 2026

Status verified date

May, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Age 18-55 years
  • History of suicidal ideation within the past 6 months
  • Habitual bedtime between 9:00 PM and 1:00 AM
  • Habitual wake time between 6:00 AM and 9:00 AM
  • Ability to provide informed consent

Exclusion Criteria:

  • Current suicidal intent requiring immediate clinical intervention
  • Diagnosis of a primary sleep disorder (e.g., untreated obstructive sleep apnea, narcolepsy)
  • Bipolar disorder or psychotic disorder
  • Substance use disorder within the past 3 months
  • Use of medications that significantly affect sleep or circadian rhythms
  • Night shift work or transmeridian travel within the past month
  • Medical or neurological condition that would interfere with participation
  • Pregnancy

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: High Sleep Pressure Condition

Participants will remain awake until 2:00 AM to induce high homeostatic sleep pressure. During the biological night (2:00-4:00 AM), participants will complete assessments of mood, suicidal ideation, impulsivity, and decision-making under conditions of sustained wakefulness.

experimental: Low Sleep Pressure Condition

Participants will be allowed to sleep and will be awakened at 2:00 AM to induce lower homeostatic sleep pressure. During the biological night (2:00-4:00 AM), participants will complete assessments of mood, suicidal ideation, impulsivity, and decision-making following sleep and acute awakening.

Interventions

Sleep Pressure Manipulation

Participants undergo an experimental manipulation of homeostatic sleep pressure involving controlled wakefulness or scheduled awakening during the biological night. Mood, suicidal ideation, impulsivity, and decision-making are assessed during overnight laboratory sessions.

Primary outcome measure

  • Feelings of Hopelessness [ Time Frame: Visit 1(day 2, night 2), Visit 2 (day 2, night 2) ]
  • Impaired Executive Function [ Time Frame: Visit 1(day 2, night 2), Visit 2 (day 2, night 2) ]
  • Negative Mood [ Time Frame: Visit 1(day 2, night 2), Visit 2 (day 2, night 2) ]

Central Contacts and Locations

Central contacts

Denisse Armenta

5206261737armentamd@arizona.edu

Darilyn Rivera-Collazo, MS

5206264746darilyn@arizona.edu

Locations

University of Arizona - Center for Sleep, Circadian, and Neuroscience Research

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Darilyn Rivera-Collazo, MS

520-626-4746darilyn@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Nocturnal Wakefulness
  • Suicide Risk
  • Circadian Misalignment
  • Impulsivity
  • Mood Regulation
  • Biological Night
  • Sleep Pressure
  • Decision-Making

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-05-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.