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. 2023 Jan 3;2023(1):CD011881. doi: 10.1002/14651858.CD011881.pub2

McCurry 2005.

Study characteristics
Methods Study design: RCT
Follow‐up: 2 months
Participants Country: USA
Setting: independent living (with informal carers)
Inclusion criteria:

  • probable or possible Alzheimer's disease

  • ≥ 2 sleep problems


Exclusion criteria:

  • primary sleep disorder (e.g. sleep apnoea, periodic leg movement disorder)


Baseline characteristics:
Patients:

  • age (years, mean): IG 77.8 (SD 8.1), CG 77.6 (SD 6.7)

  • gender (female): IG 41.2%, CG 47.4%

  • sleep medication use: IG 23.5%, CG 36.8%

  • night‐time behaviour/sleep scale (mean): IG 4.1 (SD 1.1), CG 4.2 (SD 1.8)

  • MMSE (mean): IG 9.9 (SD 7.6), CG 13.6 (SD 9.0)


Carers:

  • age (years, mean): IG 62.8 (SD 15.3), CG 63.7 (SD 16.7)

  • gender (female): IG 76.5%, CG 68.4%


Number of participants completing the study: 36 (IG 17, CG 19)
Group differences: no differences reported
Interventions Intervention: night‐time insomnia treatment (education about sleep hygiene, daily walks, decreased daytime sleep/in bed and increased daylight exposure) for 2 months. This consisted of 1. the development of an individual sleep hygiene programme for participants by carers; 2. participant walked daily for 30 minutes; and 3. increased daytime light exposure via a SunRay light box (2500 lux). Light intervention performed within a 3‐hour window before participants went to bed. Interventions performed over 3 weekly treatment sessions by a gerontopsychologist experienced in behavioural interventions with people with dementia.
Control: non‐directive, supportive approaches and provided information about general dementia care. This consisted of 1. offering sleep‐related reading materials at baseline; the interventionist was available for questions about the materials during the intervention period, offered general information and support, information about general dementia care and community resources if requested, but no specific recommendations about hygiene‐related issues; 3. carers were encouraged spending 1 hour per day with their participants and engaging them in pleasant activities of their choice to control for the increased carer attention in the intervention group.
Outcomes

  • Night‐time total wake, minutes (actigraphy)

  • Night‐time number of awakenings (actigraphy)

  • Percentage of time asleep (actigraphy)

  • Duration of night awakenings (actigraphy)
Funding Sponsorship source:

  • Grants MH01644

  • AG13757, MH01158

  • P10‐1999‐1800
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Sequence generation Low risk Patient–carer dyads were randomly assigned to NITE‐AD or to a contact control condition. Dyads were randomised after the baseline assessment using a random numbers table that blocked groups of 8–12 participants.
Allocation concealment Unclear risk No information.
Blinding of participants and personnel
All outcomes Unclear risk Unknown.
Blinding of participants and personnel
Subjective sleep quality (carer ratings) Unclear risk Unknown.
Blinding of participants and personnel
Objective sleep measures Unclear risk Unknown.
Blinding of outcome assessors
Objective outcome measures Low risk Actigraphy.
Blinding of outcome assessors
Subjective sleep quality (carer ratings) Unclear risk No information available.
Incomplete outcome data
All outcomes Low risk No information.
Selective outcome reporting Unclear risk No protocol identified.
Other sources of bias Low risk None.