Sleep Architecture, Cognitive Function, and Quality of Life During Early Recovery From Substance Use Disorder
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.
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).
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
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.
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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Continuous Performance Task (CPT) Reaction-Time Variability
Tidsramme: 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. |
Baseline and 3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Sleep in SUD Early Recovery
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .