Substance-Related DisordersNCT07852052
Sleep Architecture, Cognitive Function, and Quality of Life During Early Recovery From Substance Use Disorder
An observational study of Substance-Related Disorders and Substance Use Disorder, run by Assiut University.
Trial summary
This prospective cohort study investigates how sleep disturbances affect cognitive recovery and quality of life during early recovery from substance use disorder (SUD). Chronic substance use frequently alters normal sleep architecture, which may impair attention, memory, and everyday functioning. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Substance-Related Disorders, Substance Use Disorder, Sleep Wake Disorders
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
Study population: Adult patients aged 18 to 45 years diagnosed with a primary Substance Use Disorder according to DSM-5 criteria, admitted to inpatient wards or followed at outpatient clinics of the Neuropsychiatry Department at Assiut University Hospitals. A comparison group of age-, sex-, and education-matched adults without a substance use disorder is recruited from the local community, screened for the same psychiatric and sleep disorder exclusions, and matched on shift-work status as well as caffeine and nicotine consumption.
Who may be able to join
- Substance Use Disorder (SUD) Cohort:
- Age between 18 and 45 years.
- Fulfillment of DSM-5 diagnostic criteria for a primary Substance Use Disorder.
- Admitted to inpatient wards or followed in outpatient neuropsychiatry services.
- Resolution of acute intoxication and clinically significant withdrawal prior to sleep assessment.
- Availability and willingness to complete baseline evaluations and prospective 1-month and 3-month follow-up assessments.
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- Matched Control Cohort:
- Age between 18 and 45 years.
- Absence of current or lifetime Substance Use Disorder.
- Matched to the SUD cohort by age, sex, education level, shift-work status, and caffeine/nicotine use.
- Availability and willingness to complete baseline and follow-up assessments.
Who cannot join
- Primary major independent psychiatric disorders predating the onset of substance use (e.g., schizophrenia, bipolar disorder).
- Pre-existing primary sleep disorders independent of substance use (e.g., previously diagnosed severe obstructive sleep apnea, narcolepsy).
- Current intake of prescription medications known to severely alter sleep architecture or cognitive function (e.g., chronic benzodiazepines, high-dose antipsychotics, antiepileptics).
- History of severe traumatic brain injury, neurological illness, or structural brain lesions.
- Acute psychiatric instability requiring urgent emergency clinical intervention.
- Impaired capacity to provide informed consent or conditions preventing valid completion of sleep studies or cognitive testing.
- Refusal to participate or withdrawal of consent.
About this study
Official title: Sleep Architecture, Cognitive Function, and Quality of Life During Early Recovery From Substance Use Disorder: A Controlled Prospective Cohort Study With Three-Month Follow-Up
This prospective cohort study investigates how sleep disturbances affect cognitive recovery and quality of life during early recovery from substance use disorder (SUD). Chronic substance use frequently alters normal sleep architecture, which may impair attention, memory, and everyday functioning. The primary aim is to characterize baseline sleep patterns in adults with SUD compared to healthy control participants and determine whether baseline sleep disruptions predict cognitive and functional recovery over three months of monitored abstinence.
The study includes two groups of participants aged 18 to 45 years: adults diagnosed with a primary substance use disorder undergoing treatment and monitored abstinence, and a comparison group of healthy volunteers matched for age, sex, education, work schedule, and caffeine or nicotine use.
Read more
At the beginning of the study, all participants complete:
- Structured diagnostic interviews and clinical assessments for mood, anxiety, and attention.
- Questionnaires evaluating subjective sleep quality (Pittsburgh Sleep Quality Index) and quality of life (WHOQOL-BREF).
- A global cognitive screening test (Montreal Cognitive Assessment) and a computerized attention test (Continuous Performance Task).
- An overnight sleep study (polysomnography) conducted in a sleep laboratory following an initial adaptation night to objectively record brain waves, sleep stages, oxygen levels, and sleep continuity.
Participants in the substance use disorder group undergo supervised abstinence monitoring via periodic clinical check-ins and random urine drug screens. At 1 month and 3 months post-baseline, participants repeat the cognitive tests, quality-of-life questionnaires, and mood/sleep assessments to track recovery trajectories over time (no repeat overnight sleep studies are performed).
- Conditions
- Substance-Related Disorders, Substance Use Disorder, Sleep Wake Disorders, Cognitive Dysfunction
- Keywords
- Polysomnography, Sleep Architecture, Continuous Performance Task, Cognitive Function, Quality of Life, Substance Abstinence, Pittsburgh Sleep Quality Index, Montreal Cognitive Assessment
- Medical subject headings
- Substance-Related Disorders, Sleep Wake Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Substance Use Disorder (SUD) Group | Adult patients aged 18 to 45 years fulfilling DSM-5 diagnostic criteria for a primary Substance Use Disorder recruited from the inpatient wards and outpatient clinics of the Neuropsychiatry Department at Assiut University Hospitals. Participants undergo monitored abstinence and receive baseline clinical evaluations, structured psychiatric assessment (SCID-5, PHQ-9, GAD-7, ASRS), subjective sleep quality assessment (PSQI), and overnight polysomnography (PSG). Follow-up prospective assessments of cognitive function (Continuous Performance Task, MoCA), quality of life (WHOQOL-BREF), and subjective sleep are completed at 1 month and 3 months. | |
| Matched Healthy Control Group | Adult volunteers aged 18 to 45 years without a Substance Use Disorder, matched to the SUD cohort by age, sex, education level, shift-work status, and caffeine/nicotine use. Participants are screened to rule out primary sleep, psychiatric, or neurological disorders and complete baseline clinical evaluations, psychiatric questionnaires, subjective sleep assessment (PSQI), and overnight polysomnography (PSG), followed by cognitive and quality of life assessments at 1 month and 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Continuous Performance Task (CPT) Reaction-Time Variability
Assessed using a 14-minute computerized Continuous Performance Task (CPT) to evaluate sustained attention. It is calculated as the change in reaction-time standard deviation (in milliseconds) on correct target trials from baseline to the 3-month follow-up. A negative change score indicates improved stability of sustained attention.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Ragab Mohamed Abdrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852052
- Sponsor's protocol ID
- Sleep in SUD Early Recovery
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Architecture, Cognitive Function, and Quality of Life During Early Recovery From Substance Use Disorder: A Controlled Prospective Cohort Study With Three-Month Follow-Up
- ClinicalTrials.gov ID
- NCT07852052
- Acronym / sponsor ID
- Sleep in SUD Early Recovery
- Conditions
- Substance-Related Disorders, Substance Use Disorder, Sleep Wake Disorders, Cognitive Dysfunction
- Keywords
- Polysomnography, Sleep Architecture, Continuous Performance Task, Cognitive Function, Quality of Life, Substance Abstinence, Pittsburgh Sleep Quality Index, Montreal Cognitive Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study investigates how sleep disturbances affect cognitive recovery and quality of life during early recovery from substance use disorder (SUD). Chronic substance use frequently alters normal sleep architecture, which may impair attention, memory, and everyday functioning. The primary aim is to characterize baseline sleep patterns in adults with SUD compared to healthy control participants and determine whether baseline sleep disruptions predict cognitive and functional recovery over three months of monitored abstinence.
The study includes two groups of participants aged 18 to 45 years: adults diagnosed with a primary substance use disorder undergoing treatment and monitored abstinence, and a comparison group of healthy volunteers matched for age, sex, education, work schedule, and caffeine or nicotine use.
At the beginning of the study, all participants complete:
- Structured diagnostic interviews and clinical assessments for mood, anxiety, and attention.
- Questionnaires evaluating subjective sleep quality (Pittsburgh Sleep Quality Index) and quality of life (WHOQOL-BREF).
- A global cognitive screening test (Montreal Cognitive Assessment) and a computerized attention test (Continuous Performance Task).
- An overnight sleep study (polysomnography) conducted in a sleep laboratory following an initial adaptation night to objectively record brain waves, sleep stages, oxygen levels, and sleep continuity.
Participants in the substance use disorder group undergo supervised abstinence monitoring via periodic clinical check-ins and random urine drug screens. At 1 month and 3 months post-baseline, participants repeat the cognitive tests, quality-of-life questionnaires, and mood/sleep assessments to track recovery trajectories over time (no repeat overnight sleep studies are performed).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substance Use Disorder (SUD) Group | – | –Adult patients aged 18 to 45 years fulfilling DSM-5 diagnostic criteria for a primary Substance Use Disorder recruited from the inpatient wards and outpatient clinics of the Neuropsychiatry Department at Assiut University Hospitals. Participants undergo monitored abstinence and receive baseline clinical evaluations, structured psychiatric assessment (SCID-5, PHQ-9, GAD-7, ASRS), subjective sleep quality assessment (PSQI), and overnight polysomnography (PSG). Follow-up prospective assessments of cognitive function (Continuous Performance Task, MoCA), quality of life (WHOQOL-BREF), and subjective sleep are completed at 1 month and 3 months. |
| Matched Healthy Control Group | – | –Adult volunteers aged 18 to 45 years without a Substance Use Disorder, matched to the SUD cohort by age, sex, education level, shift-work status, and caffeine/nicotine use. Participants are screened to rule out primary sleep, psychiatric, or neurological disorders and complete baseline clinical evaluations, psychiatric questionnaires, subjective sleep assessment (PSQI), and overnight polysomnography (PSG), followed by cognitive and quality of life assessments at 1 month and 3 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adult patients aged 18 to 45 years diagnosed with a primary Substance Use Disorder according to DSM-5 criteria, admitted to inpatient wards or followed at outpatient clinics of the Neuropsychiatry Department at Assiut University Hospitals. A comparison group of age-, sex-, and education-matched adults without a substance use disorder is recruited from the local community, screened for the same psychiatric and sleep disorder exclusions, and matched on shift-work status as well as caffeine and nicotine consumption.
Key inclusion criteria (11 listed)
- Age between 18 and 45 years.
- Fulfillment of DSM-5 diagnostic criteria for a primary Substance Use Disorder.
- Admitted to inpatient wards or followed in outpatient neuropsychiatry services.
- Resolution of acute intoxication and clinically significant withdrawal prior to sleep assessment.
- Availability and willingness to complete baseline evaluations and prospective 1-month and 3-month follow-up assessments.
Key exclusion criteria (7 listed)
- Primary major independent psychiatric disorders predating the onset of substance use (e.g., schizophrenia, bipolar disorder).
- Pre-existing primary sleep disorders independent of substance use (e.g., previously diagnosed severe obstructive sleep apnea, narcolepsy).
- Current intake of prescription medications known to severely alter sleep architecture or cognitive function (e.g., chronic benzodiazepines, high-dose antipsychotics, antiepileptics).
- History of severe traumatic brain injury, neurological illness, or structural brain lesions.
- Acute psychiatric instability requiring urgent emergency clinical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Continuous Performance Task (CPT) Reaction-Time Variability
Time frame: Baseline and 3 months
Assessed using a 14-minute computerized Continuous Performance Task (CPT) to evaluate sustained attention. It is calculated as the change in reaction-time standard deviation (in milliseconds) on correct target trials from baseline to the 3-month follow-up. A negative change score indicates improved stability of sustained attention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance-Related Disorders and Substance Use Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Continuous Performance Task (CPT) Reaction-Time Variability (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.