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Sleep Architecture, Cognitive Function, and Quality of Life During Early Recovery From Substance Use Disorder

2026年9月25日 更新者:Hussein Ragab Mohamed Abdrahman、Assiut University

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).

調査の概要

状態

まだ募集していません

研究の種類

観察的

入学 (推定)

34

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~45年 (大人)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Continuous Performance Task (CPT) Reaction-Time Variability
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年9月25日

QC基準を満たした最初の提出物

2026年9月25日

最初の投稿 (実際)

2026年10月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月25日

最終確認日

2026年9月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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