Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality (SLEEP-ARTerY)
Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality
調査の概要
状態
詳細な説明
Background: Poor sleep quality is associated with increased arterial stiffness, depression, and cognitive decline, all of which contribute to cardiovascular risk in hypertensive patients. This trial tests whether improving sleep through CBT-I can attenuate arterial dysfunction and psychological/cognitive burden.
Design: Prospective, single-centre, parallel-group randomised controlled trial with 1:1 allocation, conducted at the Hypertension and Psychiatry Outpatient Clinics of the Unidade Local de Saude Alto Ave (ULSAAVE).
Intervention: CBT-I delivered in four weekly 60-minute sessions (sleep hygiene, stimulus control, relaxation techniques), adapted for participants with mild obstructive sleep apnea or comorbid insomnia and sleep apnea (COMISA).
Comparator: Passive sleep education (informational leaflets plus non-interactive follow-up calls); control participants are offered CBT-I after study completion.
Randomisation and blinding: Computer-generated block randomisation (blocks of 4-6), 1:1 allocation, with allocation concealment via sequentially numbered, opaque, sealed envelopes managed by a third party. Outcome assessors and data analysts are blinded; participants are partially blinded (control presented as an educational intervention).
Sample size: 234 participants (117 per group), accounting for 20% attrition, powered (80%, alpha 0.05) to detect a 0.4 m/s between-group difference in pulse wave velocity at 12 months.
Analysis: Linear mixed-effects models for repeated measures (time as fixed effect, participant as random effect, group as factor), with baseline apnea-hypopnea index included as a covariate.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sofia Gomes, MD
- 電話番号：+ 351 253540330
- メール：3603@ulsaave.min-saude.pt
研究場所
-
-
Braga District
-
Guimarães、Braga District、ポルトガル、4835-044
- 募集
- Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
-
コンタクト：
- Sofia Gomes, MD
- 電話番号：+351 253 540 330
- メール：3603@ulsaave.min-saude.pt
-
コンタクト：
- Pedro Cunha, PhD
- 電話番号：+351 253 540 330
- メール：pedrocunha@ulsaave.min-saude.pt
-
主任研究者：
- Sofia Gomes
-
副調査官：
- Ana Daniela Ferreira
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 to 70 years
- Controlled hypertension
- Poor baseline sleep quality (sleep efficiency <=85% assessed via actigraphy or type II polysomnography)
- Capable of providing informed consent
- Participants with mild obstructive sleep apnea (apnea-hypopnea index 5-14.9/h on type II polysomnography) who do not meet criteria for CPAP/PAP therapy are eligible
Exclusion Criteria:
- Severe cardiovascular disease (e.g., acute myocardial infarction or stroke)
- Severe neurological diseases
- Moderate-to-severe obstructive sleep apnea (AHI >=15/h) or any obstructive sleep apnea with an indication for CPAP/PAP therapy
- Central disorders of hypersomnolence
- Intellectual disability
- Pregnancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CBT-I
Cognitive-behavioural therapy for insomnia: four weekly 60-minute sessions covering sleep hygiene, stimulus control, and relaxation techniques, adapted for participants with mild obstructive sleep apnea or COMISA.
|
Cognitive-behavioural therapy for insomnia delivered in four weekly 60-minute sessions, incorporating sleep hygiene, stimulus control, and relaxation techniques.
Based on baseline polysomnography, the protocol is adapted for participants without obstructive sleep apnea, with mild obstructive sleep apnea, or with comorbid insomnia and mild sleep apnea (COMISA).
|
|
アクティブコンパレータ：Passive sleep education
Informational leaflets plus non-interactive follow-up calls.
Control participants are offered CBT-I after study completion.
|
Passive sleep education consisting of informational leaflets plus non-interactive follow-up calls.
Participants in this control condition are offered access to CBT-I after study completion.
|
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 pulse wave velocity (PWV)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in carotid-femoral pulse wave velocity (m/s), a marker of arterial stiffness.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in central arterial pressure (CAP)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in central arterial pressure (mmHg).
|
Baseline, 1 month, 6 months, and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in blood pressure
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in systolic and diastolic blood pressure (mmHg)
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in body weight
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in body weight (kg).
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in body mass index (BMI)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in body mass index (kg/m^2).
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in depressive symptoms (MADRS)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
Scores range from 0 to 60, with higher scores indicating more severe depression.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in depressive symptoms (PHQ-9)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).
Scores range from 0 to 27, with higher scores indicating more severe depression.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in perceived stress (PSS)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS).
Higher scores indicate greater perceived stress.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in cognitive function (MoCA)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in cognitive function measured by the Montreal Cognitive Assessment (MoCA).
Scores range from 0 to 30, with lower scores indicating greater cognitive impairment.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in sleep quality (PSQI)
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI).
Scores range from 0 to 21, with higher scores indicating worse sleep quality.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from baseline in sleep efficiency
時間枠：Baseline, 1 month, 6 months, and 12 months
|
Change from baseline in sleep efficiency (%) assessed via actigraphy or type II polysomnography.
|
Baseline, 1 month, 6 months, and 12 months
|
協力者と研究者
捜査官
- 主任研究者：Sofia Gomes, MD、Unidade Local de Saúde do Alto Ave
- スタディディレクター：Pedro Cunha, PhD、Unidade Local de Saúde do Alto Ave
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CIC20260049 - CAIDIS (その他の識別子：ULSAAVE Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。