NCT07438912

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
41mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Aug 2029

First Submitted

Initial submission to the registry

February 11, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 11, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

Nocturnal WakefulnessSuicide RiskCircadian MisalignmentImpulsivityMood RegulationBiological NightSleep PressureDecision-Making

Outcome Measures

Primary Outcomes (3)

  • Feelings of Hopelessness

    Total score on the BECK Hopelessness scale (BHS)

    Visit 1(day 2, night 2), Visit 2 (day 2, night 2)

  • Impaired Executive Function

    BART total score

    Visit 1(day 2, night 2), Visit 2 (day 2, night 2)

  • Negative Mood

    PANAS negative affect score

    Visit 1(day 2, night 2), Visit 2 (day 2, night 2)

Study Arms (2)

High Sleep Pressure Condition

EXPERIMENTAL

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.

Behavioral: Sleep Pressure Manipulation

Low Sleep Pressure Condition

EXPERIMENTAL

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.

Behavioral: Sleep Pressure Manipulation

Interventions

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.

High Sleep Pressure ConditionLow Sleep Pressure Condition

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Suicidal IdeationChronobiology DisordersSleep DeprivationSleep Wake DisordersImpulsive Behavior

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorNervous System DiseasesDyssomniasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Michael A Grandner, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denisse Armenta

CONTACT

Darilyn Rivera-Collazo, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is open-label. Participants and study personnel are aware of the assigned sleep pressure condition (high sleep pressure or low sleep pressure), as the experimental manipulation involves remaining awake or being awakened during the biological night.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will complete laboratory assessments under two experimental sleep pressure conditions in a within-subject crossover design. In one condition, participants will remain awake until 2:00 AM (high sleep pressure). In the other condition, participants will sleep and be awakened at 2:00 AM (low sleep pressure). Mood, suicidal ideation, and decision-making will be assessed during the biological night under both conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations