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. 2020 Dec 2;30(4):e13229. doi: 10.1111/jsr.13229

Table 1.

Individual Study Characteristics

Author/Year Condition/ Diagnosis Sleep Co‐Morbidity Status Country No. Total (Female) Mean Age (SD) Study Type Intervention Treatment Dosage/ Duration Control Validated Outcome Measure Sleep Parameters Evaluated
Cassidy‐Eagle et al. (2018a) and Cassidy‐Eagle et al. (2018b)a MCI Insomnia (DSM IV Criteria) United States 27 (‐) 89.4 Randomised Controlled Trial Cognitive Behavioural Therapy ‐ Insomnia Six 1‐hr sessions Active control class

Wrist Actigraphy

ISI

TST, SE, WASO, SL

ISI Total

Cooke et al. (2006) Mild to Moderate AD Sleep/ OSA Co‐Morbidities Excluded United States 76 (25)

IG1 77.8 (7.4)

IG2 77.6 (11.5)

IG3 79.8 (8.3)

CG 78.3 (6.2)

Prospective Study

Donepezil

Galantamine

Rivastigmine

On stable dose of AChE Inhibitor for 2 months Non Medication Arm Polysomnography TST, SE, WASO, SP, %REM, %N1, %N2, %N3/N4, TIB, PLMI, AI, AH
Cooke, et al. (2009))

Mild to Moderate AD with OSA

OSA only United States 52 (13) 77.8 (7.3) Randomised Controlled Trial CPAP

Therapeutic CPAP for 3 weeks in intervention arm

Therapeutic CPAP for 3 weeks in both arms

Placebo CPAP Polysomnography TST, SE, WASO, SL, SP, %REM, %N1, %N2, %N3/N4, TIB, AI
Cooke, et al. (2009)) Mild AD with OSA OSA only United States 10 (3) 75.7 (5.9) Prospective Study CPAP Continued use’ over approximately 3 years Non Intervention Arm

PSQI

ESS

FOSQ

PSQI Total

ESS Total

FOSQ Total

Cruz‐Aguilar et al. (2018) and Cruz‐Aguilar et al. (2020)b Mild to Moderate AD ‘Alteration to Sleep Pattern’ determined clinically Mexico 8 (‐) 65.6 (2.9) Single Blind Placebo Controlled Crossover Study Melatonin 5 mg nocte for 1 day Placebo crossover for 1 day Polysomnography SL, NREM SL, NREM Relative Power, NREM EEG Coherence
Fultz et al. (2019) Mild to Moderate AD Insomnia (DSM V Criteria) United States 285 (186)

IG 69.6 (8.7)

CG 69.1 (8.5)

Randomised Controlled Trial Suvorexant 28 day total period. 10 mg nocte for 14 days escalated to 20 mg nocte if insufficient response Placebo Arm Polysomnography TST, SE, WASO, SL, %REM, %N1, %N2, %N3/N4, AI, REM SL
Jean‐Louis et al., 1998

MCI and Mild AD

Self reported sleep‐wake disturbance United States 10 (6) 68.8 Double‐Blind Crossover Trial Melatonin 6 mg nocte for 10 days Placebo Arm Wrist Actigraphy TST, SE, WASO, SL, Transition, TWT
Kouzuki et al. (2020) MCI and Mild AD Mixed Population ± Sleep Disorder Japan 35 (18)

IG1 76

IG2 78

IG3 82

Randomised Controlled Trial Aromatherapy (Aroma Oil as Bath Salt) 3 armed trial with 0.1%, 0.5% and 1% strengths Multiple Treatment Arms PSQI ‐J PSQI TST, SE, SL, Total, Daytime Dysfunction, Sleep Disturbances, Subjective Sleep Quality
Ladenbauer et al. (2017) MCI Participants with significantly reduced SWS excluded Germany 16 (7) 71 (9) Randomised Crossover Trial Transcranial Stimulation Anodal current applied via electrodes at frontal locations F3 and F4, oscillated sinusoidally at 0.75 Hz [0–265 µA) Sham Stimulation Polysomnography TST, WASO, %REM, %N1, %N2, %N3/N4, EEG Slow Oscillation and Spindle Characteristics, Spectral Power
Markowitz et al. (2003) Mild to Moderate AD Mixed Population ± Sleep Disorder

Canada

New Zealand

South Africa

UK

USA

Belgium

261 (157)

IG 75.3 (7.5)

CG 74.6 (7.6)

Randomised Controlled Trial Galantamine 12 mg bd Placebo Arm PSQI PSQI TST, SE, SL, Total, Daytime Dysfunction, Sleep Disturbances, Subjective Sleep Quality
Moraes et al. (2006) Mild to Moderate AD Moderate/ Severe Sleep Disorders excluded Brazil 35 (24)

IG 77.4 (6.6)

CG 74.5 (9.8)

Randomised Controlled Trial Donepezil 5 mg od for 1 month increasing to 10 mg od Placebo Arm

Polysomnography

EEG Spectral Analysis

TST, SE, SL, %REM, %N1, %N2, %N3/N4, PLMI, AH, REM Characteristics
Naharci et al., (2015) AD and Mixed Dementia Mixed Population ± Sleep Disorder Turkey 78 (47)

IG1 81.5 (6.9)

IG2 80.9 (7.4)

IG3 79.1 (7.7)

CG 77.4 (66.3)

Prospective Study

Donepezil

Galantamine

Rivastigmine

5−10 cm2 od

5−10 mg od

8, 16, 24 mg od

Healthy Population PSQI PSQI Total
Naismith et al. (2018) MCI Primary Sleep Disorder excluded Australia 35 (19)

IG1 69.4 (9.5)

CG 70.0 (8.8)

Randomised Controlled Trial “Sleep Well, Think Well” Group Program 8 week group program (Four 1 hr face to face sessions and four telephone session) Non‐directive Control Group

PSQI

ESS

Wrist Actigraphy

TST, SE, WASO

PSQI Total

ESS Total

Papalambros et al. (2019) MCI Circadian Rhythm Disorders/ OSA excluded United States 9 (5) 72 Randomised Crossover Trial Phase Locked Loop Acoustic Stimulation Parameters for stimulation as per previous established algorithm (Santostasi et al., 2016) Sham Stimulation Polysomnography TST, SE, WASO, SL, %REM, %N1, %N2, %N3/N4, AI, Spindle Characteristics
Petit et al. (1993) Mild to Moderate AD Mixed Population ± Sleep Disorder Canada 8 (3) 61.9 Double‐Blind Crossover Trial Tetrahydroaminoacridine (THA)

50 mg od for 1 week

75−100 mg od for subsequent week

Placebo Period Polysomnography SE, SL, %REM, %N1, %N2, %N3/N4, REM Characteristics
Wang et al, (2020) MCI Mixed Population ± Sleep Disorder China 111 (68)

IG 68.4 (5.3)

CG 68.2 (5.1)

Randomised Controlled Trial Structured Limbs Exercise Program Three 60 min exercise sessions per week for 12 weeks. Two Health Promotion Classes over 12 weeks Health Promotion Classes only PSQI PSQI Total

Abbreviations: AH, Apnoea Hypopnoea Index; AI, Arousal Index; CG, Control Group; DSM, Diagnostic and Statistical Manual; ESS, Epworth Sleepiness Scale; FOSQ, Functional Outcomes of Sleep Questionnaire; IG, Intervention Group; ISI, Insomnia Severity Index; NINCDS‐ADRDA ‐ National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association; OSA, Obstructive Sleep Apnoea; PLMI, Periodic Limb Movement Index; PSQI, Pittsburgh Sleep Quality Index; REM, Rapid Eye Movement; SE, Sleep Efficiency; SL, Sleep Latency; TIB, Time in Bed; TST, Total Sleep Time; TWT, Total Wake Time; WASO, Wake After Sleep Onset.

a

2 separate papers written by Cassidy‐Eagle reporting data from the same study. Analysis was focussed on paper reporting sleep outcome measures in more detail to avoid over‐representation of data. Quality appraisal and risk of bias assessment identical due to same study design.

b

2 separate papers written by Cruz‐Aguilar reporting data from the same study. Analysis focussed on combined findings. Quality appraisal and risk of bias assessment identical due to same study design.